78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04867317 (ClinicalTrials.gov) | March 1, 2022 | 8/4/2021 | AGH Replacement Therapy With mTBI | CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency;Mild Traumatic Brain Injury | Drug: Somatropin;Other: Placebo | VA Office of Research and Development | NULL | Not yet recruiting | 21 Years | 55 Years | All | 172 | Phase 3 | United States |
| 2 | NCT05250063 (ClinicalTrials.gov) | February 18, 2022 | 10/2/2022 | Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial LUM-201-01 Trial (OraGrowtH213 Trial) | A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 Trial | Growth Hormone Deficiency | Drug: LUM-201 | Lumos Pharma | NULL | Enrolling by invitation | 3 Years | 13 Years | All | 20 | Phase 2 | United States |
| 3 | NCT05230550 (ClinicalTrials.gov) | February 3, 2022 | 28/1/2022 | Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® | Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan | Adult Growth Hormone Deficiency | Drug: Somapacitan | Novo Nordisk A/S | NULL | Enrolling by invitation | N/A | N/A | All | 200 | Japan | |
| 4 | EUCTR2020-000929-42-BG (EUCTR) | 07/01/2022 | 20/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 5 | NCT05171855 (ClinicalTrials.gov) | December 16, 2021 | 24/9/2021 | A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency | A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Endocrine System Diseases;Hormone Deficiency | Drug: Lonapegsomatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Recruiting | 23 Years | 81 Years | All | 240 | Phase 3 | United States |
| 6 | JPRN-jRCT2031210366 | 15/11/2021 | 05/10/2021 | An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Growth hormone deficiency in children | [Investigational product] JR-142 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin 0.175 mg/kg/week, daily subcutaneous injection | Ioroi Minoru | NULL | Not Recruiting | Not applicable | Not applicable | Both | 24 | Phase 2 | Japan |
| 7 | EUCTR2020-000929-42-IT (EUCTR) | 18/10/2021 | 08/06/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: [ACP-011] INN or Proposed INN: lonapegsomatropin Product Name: lonapegsomatropin drug product Product Code: [ACP-011] INN or Proposed INN: lonapegsomatropin Product Name: Norditropin FlexPro 5mg/1.5 ml Product Code: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 8 | NCT04786873 (ClinicalTrials.gov) | September 2021 | 3/3/2021 | A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is | Multicenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: Macimorelin;Diagnostic Test: Arginine;Diagnostic Test: Clonidine | AEterna Zentaris | Novo Nordisk A/S | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States |
| 9 | EUCTR2020-000929-42-DK (EUCTR) | 05/08/2021 | 12/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 10 | NCT04938466 (ClinicalTrials.gov) | August 5, 2021 | 16/6/2021 | Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy | Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy | Growth Hormone Deficiency;Growth Hormone Treatment | Drug: Long-Acting Growth Hormone (LAGH) | University of Minnesota | NULL | Recruiting | 2 Years | 13 Years | All | 80 | United States | |
| 11 | EUCTR2018-001989-42-PL (EUCTR) | 04/08/2021 | 29/06/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial | Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macimorelin Consilient Health Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: macimorelin Other descriptive name: MACIMORELIN ACETATE Trade Name: R-Gene 10 Product Name: Arginine Hydrochloride Product Code: NDC0009-0436-01 INN or Proposed INN: Arginine Hydrochloride Other descriptive name: ARGININE HYDROCHLORIDE Trade Name: Catapresan 75 Product Name: Clonidine Hydrochloride INN or Proposed INN: Clonidine hydrochloride Other descriptive name: CLONIDINE HYDROCHLORIDE | Aeterna Zentaris GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy | ||
| 12 | EUCTR2018-001989-42-IT (EUCTR) | 03/08/2021 | 30/08/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial | Diagnosis of growth hormone deficiency in pediatric subjects MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Catapresan 75 Product Name: Clonidine Hydrochloride Product Code: [-] INN or Proposed INN: CLONIDINA CLORIDRATO Other descriptive name: Clonidine hydrochloride Trade Name: Macimorelin Consilient Health Product Name: Macimorelin Product Code: [AEZS-130] INN or Proposed INN: macimorelina Other descriptive name: MACIMORELIN ACETATE Trade Name: R-Gene Product Name: Arginine Hydrochloride Product Code: [NDC0009-0436-01] INN or Proposed INN: ARGININA CLORIDRATO Other descriptive name: ARGININE HYDROCHLORIDE | AETERNA ZENTARIS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;United Kingdom;Italy | ||
| 13 | ChiCTR2100048579 | 2021-08-01 | 2021-07-11 | Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency | Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency (TGHD) | Transitional Growth Hormone Deficiency | Experimental group:polyethylene glycol recombinant human growth hormone injection; | The Children's Hospital of Zhejiang University School of Medicine | NULL | Pending | 26 | Both | Experimental group:23; | Phase 4 | China | |
| 14 | NCT04970654 (ClinicalTrials.gov) | July 22, 2021 | 12/7/2021 | A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. | A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency | Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® | Novo Nordisk A/S | NULL | Recruiting | 2 Years | 11 Years | All | 108 | Phase 3 | China |
| 15 | JPRN-jRCT2031200340 | 14/06/2021 | 02/02/2021 | A trial to compare lonapegsomatropin (TransCon hGH) administered once a week and standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the efficacy, safety, and tolerability of lonapegsomatropin (TransCon hGH) administered once a week versus standard daily hGH replacement therapy over 52 weeks in Japanese prepubertal hGH-treatment naive children with growth hormone deficiency(GHD) - riGHt | Pediatric growth hormon deficiency | Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Genotropin will be administered as daily SC injections in a standard dose of 0.24 mg hGH/kg/week. The total weekly dose will be equally split into 7 daily doses of 0.034 mg hGH/kg/day. A commercially approved injection device will be used for administration of the drug. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. Lonapegsomatropin will be administered as once weekly subcutaneous (SC) injections of 0.24 mg hGH/kg/week using GH Auto-Injector. | Beckert Michael | NULL | Recruiting | >= 3age old | <= 16age old | Both | 50 | Phase 3 | Japan |
| 16 | EUCTR2020-000929-42-DE (EUCTR) | 09/06/2021 | 14/10/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Japan;New Zealand;Germany;Bulgaria;Georgia;Romania;Poland;Canada;Armenia;United Kingdom;Turkey;Netherlands;Denmark;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 17 | JPRN-jRCT2051200129 | 02/06/2021 | 02/02/2021 | A trial to compare once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | A multicenter, randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) | -Drug: Lonapegsomatropin Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. -Other: Placebo The placebo for lonapegsonatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin. -Drug: Somatropin Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. | Beckert Michael | NULL | Recruiting | >= 23age old | <= 80age old | Both | 240 | Phase 3 | Australia;Belarus;Bulgaria;Canada;Denmark;France;Georgia;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Poland;Romania;Russia;Serbia;Slovakia;Spain;Turkey;UK;Ukraine;USA;Armenia;Japan |
| 18 | NCT04806854 (ClinicalTrials.gov) | June 2021 | 17/3/2021 | PK and PD Study of LUM-201 in Children With Growth Hormone Deficiency | A Single-Center, 6-Month, Randomized, Open-Label, Parallel Arm Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Pediatric Growth Hormone Deficiency (PGHD) | Growth Hormone Deficiency | Drug: LUM-201 | Lumos Pharma | NULL | Recruiting | 4 Years | 9 Years | All | 24 | Phase 2 | Chile |
| 19 | EUCTR2020-000929-42-ES (EUCTR) | 21/04/2021 | 01/02/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 20 | EUCTR2020-000929-42-SK (EUCTR) | 12/04/2021 | 24/11/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 21 | EUCTR2020-000929-42-GR (EUCTR) | 23/03/2021 | 04/03/2021 | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 22 | EUCTR2020-000874-92-PL (EUCTR) | 22/03/2021 | 26/10/2020 | A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD) | A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD) - LUM-201-01 | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Trade Name: Norditropin INN or Proposed INN: recombinant human growth hormone Other descriptive name: recombinant human growth hormone Trade Name: Norditropin INN or Proposed INN: recombinant human growth hormone Other descriptive name: recombinant human growth hormone | Lumos Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Poland;Ukraine;Australia;Russian Federation;Israel;New Zealand | ||
| 23 | JPRN-jRCT2031200372 | 01/03/2021 | 19/02/2021 | Phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Phase 2 study of JR-142 in pediatric patients with growth hormone deficiency | Growth hormone deficiency in children | [Investigational product] JR-142 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin 0.175 mg/kg/week, daily subcutaneous injection | Ioroi Minoru | NULL | Recruiting | >= 3age old | < 10age old | Both | 24 | Phase 2 | Japan |
| 24 | NCT04633057 (ClinicalTrials.gov) | January 25, 2021 | 12/11/2020 | A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency | A Phase III, Randomized, Open-label, Positive-controlled, Multi-center Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: TJ101;Drug: NordiFlex | I-Mab Biopharma Co. Ltd. | NULL | Recruiting | 3 Years | 12 Years | All | 165 | Phase 3 | China |
| 25 | NCT04614337 (ClinicalTrials.gov) | December 31, 2020 | 26/10/2020 | Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) | A Multicenter, 12-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve to Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: LUM-201;Drug: rhGH Norditropin® pen (34 µg/kg) | Lumos Pharma | NULL | Recruiting | 3 Years | 12 Years | All | 80 | Phase 2 | United States;Australia;Israel;New Zealand;Poland;Russian Federation;Ukraine |
| 26 | NCT04615273 (ClinicalTrials.gov) | December 3, 2020 | 29/10/2020 | A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency | foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency;Endocrine System Diseases;Hormone Deficiency | Drug: Lonapegsomatropin;Other: Placebo;Drug: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Recruiting | 23 Years | 80 Years | All | 240 | Phase 3 | United States;Armenia;Australia;Canada;Georgia;Greece;Japan;Poland;Slovakia;Turkey;Ukraine |
| 27 | ChiCTR2000039505 | 2020-12-01 | 2020-10-30 | An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency | An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency | Adult growth hormone deficiency | experimental group:Recombinant Human Growth Hormone; | Huashan Hospital Affiliated to Fudan University | NULL | Recruiting | 18 | 50 | Male | experimental group:20; | China | |
| 28 | NCT04465565 (ClinicalTrials.gov) | December 2020 | 3/7/2020 | Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test | Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study | Growth Hormone Deficiency | Procedure: 9% Sodium Chloride (NaCl) IV | Rabin Medical Center | NULL | Withdrawn | 7 Years | 16 Years | All | 0 | N/A | Israel |
| 29 | EUCTR2018-000231-27-ES (EUCTR) | 21/04/2020 | 28/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 30 | EUCTR2018-000231-27-PL (EUCTR) | 23/03/2020 | 04/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Germany;Norway;Japan;United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland | ||
| 31 | EUCTR2018-000231-27-HU (EUCTR) | 23/03/2020 | 05/02/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | ||
| 32 | EUCTR2018-000231-27-LV (EUCTR) | 05/03/2020 | 15/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;Hungary;European Union;Canada;Denmark;Germany;Latvia;Norway;Algeria;Japan;Korea, Republic of | ||
| 33 | EUCTR2018-000231-27-EE (EUCTR) | 17/02/2020 | 14/01/2020 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 34 | NCT04326374 (ClinicalTrials.gov) | December 30, 2019 | 26/3/2020 | Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency | The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in China | Growth Hormone Deficiency;Endocrine System Diseases;Hormones;Pituitary Diseases;Pituitary Disease, Anterior | Drug: TransCon hGH;Drug: daily hGH | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Ascendis Pharma A/S | Recruiting | 3 Years | 17 Years | All | 150 | Phase 3 | China |
| 35 | NCT04121780 (ClinicalTrials.gov) | October 8, 2019 | 25/9/2019 | Growth Hormone Replacement Therapy for Retried Professional Football Players | Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency | TBI (Traumatic Brain Injury);Concussion, Brain;Sport Injury;Anterior Pituitary Hyposecretion Syndrome;Hypopituitarism;Growth Hormone Deficiency | Biological: Growth Hormone;Other: Placebo | Center for Neurological Studies | Novo Nordisk A/S | Recruiting | 18 Years | 76 Years | Male | 42 | Phase 2 | United States |
| 36 | NCT04020913 (ClinicalTrials.gov) | July 22, 2019 | 24/5/2019 | Skeletal Muscle Effects of GH in Boys | Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency | Growth Hormone Deficiency;Idiopathic Short Stature | Drug: Somatropin injection | Nemours Children's Clinic | Novo Nordisk A/S | Recruiting | 6 Years | 11 Years | Male | 45 | United States | |
| 37 | EUCTR2018-000231-27-SI (EUCTR) | 17/07/2019 | 14/06/2019 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Japan | ||
| 38 | EUCTR2018-000918-38-BG (EUCTR) | 16/07/2019 | 23/05/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 39 | EUCTR2018-000918-38-SK (EUCTR) | 11/07/2019 | 11/02/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 40 | EUCTR2018-000918-38-CZ (EUCTR) | 27/06/2019 | 20/03/2019 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 41 | NCT03972345 (ClinicalTrials.gov) | June 21, 2019 | 31/5/2019 | Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | Growth Hormone Deficiency in Children;Born Small for Gestational Age | Drug: Norditropin® FlexPro® | Novo Nordisk A/S | NULL | Enrolling by invitation | N/A | 15 Years | All | 750 | Germany | |
| 42 | EUCTR2018-000231-27-GB (EUCTR) | 30/05/2019 | 03/09/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Norway;Germany;Algeria;Japan;Korea, Republic of | ||
| 43 | EUCTR2018-000231-27-AT (EUCTR) | 22/05/2019 | 02/04/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 44 | NCT03811535 (ClinicalTrials.gov) | May 20, 2019 | 18/1/2019 | A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day | A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency | Growth Hormone Deficiency in Children | Drug: Somapacitan;Drug: Norditropin® | Novo Nordisk A/S | NULL | Active, not recruiting | 2 Years | 11 Years | All | 200 | Phase 3 | United States;Algeria;Austria;Canada;Denmark;Estonia;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Norway;Poland;Russian Federation;Serbia;Slovenia;Spain;Switzerland;Thailand;Ukraine;United Kingdom |
| 45 | NCT03500913 (ClinicalTrials.gov) | May 19, 2019 | 10/4/2018 | Adipose Tissue and Serum Inflammation in GH Deficiency | Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency | Growth Hormone Deficiency | Drug: Growth Hormone | Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 18 Years | 65 Years | All | 60 | United States | |
| 46 | EUCTR2018-000918-38-GB (EUCTR) | 16/05/2019 | 27/11/2018 | STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) | Growth Hormone Deficiency in Children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somatrogon Product Code: PF-06836922 INN or Proposed INN: somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin GoQuick Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czech Republic;Slovakia;Bulgaria;United Kingdom | ||
| 47 | EUCTR2018-000231-27-DK (EUCTR) | 15/05/2019 | 28/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 48 | NCT03878992 (ClinicalTrials.gov) | April 30, 2019 | 7/3/2019 | Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle | Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle | Growth Hormone Deficiency;Growth Hormone Treatment | Drug: Genotropin miniquick 0.5 mg, injection | University of Aarhus | Aarhus University Hospital | Recruiting | 18 Years | 100 Years | All | 12 | N/A | Denmark |
| 49 | EUCTR2018-000231-27-DE (EUCTR) | 23/04/2019 | 11/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Serbia;Estonia;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;European Union;Canada;Poland;Norway;Germany;Algeria;Japan | ||
| 50 | EUCTR2018-000231-27-IT (EUCTR) | 19/04/2019 | 30/07/2021 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290S Product Code: [NN8640] INN or Proposed INN: Somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 Product Code: [NN8640] INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml Product Name: Norditropin FlexPro 10 mg/1.5 ml Product Code: [N/A] INN or Proposed INN: somatropin Other descriptive name: somatropin | NOVO NORDISK. S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Estonia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Latvia;Korea, Republic of;Slovenia;Austria;United Kingdom;Hungary;Canada;Poland;Germany;Norway;Algeria;Japan | ||
| 51 | EUCTR2018-001988-23-PL (EUCTR) | 19/04/2019 | 23/01/2019 | A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) | Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) | Diagnosis of Growth Hormone Deficiency MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macrilen Product Name: macimorelin INN or Proposed INN: macimorelin Other descriptive name: MACIMORELIN ACETATE | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Belarus;Hungary;Poland;Ukraine;Russian Federation | ||
| 52 | NCT03775993 (ClinicalTrials.gov) | March 1, 2019 | 12/12/2018 | Treatment of GHD Associated With CHF | Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study | Heart Failure;Growth Hormone Deficiency | Drug: Human growth hormone;Other: Placebo | Federico II University | NULL | Not yet recruiting | 18 Years | 85 Years | All | 64 | Phase 3 | NULL |
| 53 | NCT03831880 (ClinicalTrials.gov) | February 7, 2019 | 21/12/2018 | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | Growth Hormone Deficiency | Drug: Genotropin;Drug: somatrogon | Pfizer | NULL | Completed | 3 Years | 17 Years | All | 87 | Phase 3 | United States;Bulgaria;Czechia;Slovakia;United Kingdom |
| 54 | NCT04513171 (ClinicalTrials.gov) | December 26, 2018 | 7/8/2020 | Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children | A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency. | Growth Hormone Deficiency | Drug: Y-shape pegylated somatropin;Drug: Norditropin®;Drug: Norditropin | Xiamen Amoytop Biotech Co., Ltd. | Tongji Hospital | Recruiting | 3 Years | 11 Years | All | 400 | Phase 2/Phase 3 | China |
| 55 | EUCTR2018-001988-23-HU (EUCTR) | 07/11/2018 | 05/09/2018 | A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) | Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) | Diagnosis of Growth Hormone Deficiency MedDRA version: 20.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macrilen Product Name: macimorelin INN or Proposed INN: macimorelin Other descriptive name: MACIMORELIN ACETATE | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Ukraine;Russian Federation | ||
| 56 | EUCTR2017-003410-20-IT (EUCTR) | 30/10/2018 | 11/10/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany | ||
| 57 | EUCTR2017-003410-20-PL (EUCTR) | 23/10/2018 | 08/11/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany | ||
| 58 | ChiCTR1800017144 | 2018-07-25 | 2018-07-13 | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | Growth hormone deficiency | Two groups:low dose versus high dose of Pegylated Somatropin; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 3 | 14 | Both | Two groups:900; | China‘ | |
| 59 | EUCTR2017-003410-20-GR (EUCTR) | 04/06/2018 | 19/04/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 60 | NCT03274973 (ClinicalTrials.gov) | May 14, 2018 | 29/8/2017 | Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome | A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome | Growth Disorders | Drug: Zomacton | Ferring Pharmaceuticals | NULL | Terminated | N/A | 18 Years | All | 4 | Germany | |
| 61 | EUCTR2017-003410-20-BG (EUCTR) | 20/04/2018 | 09/01/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 62 | EUCTR2016-001145-11-DE (EUCTR) | 12/02/2018 | 14/12/2016 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine | ||
| 63 | JPRN-JapicCTI-183963 | 25/12/2017 | 17/05/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : Somatrogon (Genetical Recombination) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day). | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | NULL | complete | 3 | 11 | BOTH | 44 | Phase 3 | Japan |
| 64 | EUCTR2016-003874-42-GR (EUCTR) | 20/12/2017 | 21/11/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand | ||
| 65 | NCT03344458 (ClinicalTrials.gov) | December 19, 2017 | 14/11/2017 | A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial | enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma A/S | NULL | Active, not recruiting | 1 Year | 18 Years | All | 300 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine |
| 66 | NCT03874013 (ClinicalTrials.gov) | December 7, 2017 | 1/10/2018 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Genotropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 44 | Phase 3 | Japan |
| 67 | NCT03305016 (ClinicalTrials.gov) | November 13, 2017 | 4/10/2017 | A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency | fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma Endocrinology Division A/S | NULL | Completed | 6 Months | 17 Years | All | 146 | Phase 3 | United States;Australia;Canada;New Zealand |
| 68 | NCT03053687 (ClinicalTrials.gov) | November 1, 2017 | 7/2/2017 | Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy | Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled Trial | IGHD - Isolated Growth Hormone Deficiency;Growth Retardation | Dietary Supplement: Nutritional supplementation standardized formula;Dietary Supplement: Placebo | Rabin Medical Center | NULL | Recruiting | 3 Years | 14 Years | All | 64 | N/A | Israel |
| 69 | EUCTR2016-003874-42-GB (EUCTR) | 04/09/2017 | 03/01/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Romania;Australia;Georgia;Bulgaria;Germany;New Zealand;United States;Belarus | ||
| 70 | NCT03212131 (ClinicalTrials.gov) | August 16, 2017 | 30/6/2017 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 34 | Phase 1 | Slovakia |
| 71 | EUCTR2016-003874-42-DE (EUCTR) | 04/08/2017 | 01/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 72 | NCT03225755 (ClinicalTrials.gov) | August 1, 2017 | 19/7/2017 | Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy | Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy | Growth Hormone Deficiency | Drug: Growth hormone | Columbia University | Novo Nordisk A/S | Recruiting | 18 Years | 65 Years | All | 12 | United States | |
| 73 | NCT03186495 (ClinicalTrials.gov) | June 20, 2017 | 12/6/2017 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 44 | Phase 1 | Germany |
| 74 | EUCTR2016-003874-42-IT (EUCTR) | 16/06/2017 | 06/09/2021 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin | PRM|21097 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;Greece;Spain;Poland;Bulgaria;Germany;United Kingdom;Italy | ||
| 75 | EUCTR2016-003874-42-ES (EUCTR) | 18/05/2017 | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||
| 76 | EUCTR2016-003874-42-BG (EUCTR) | 26/04/2017 | 13/02/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | ||
| 77 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: Sterile Water for Injection | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 78 | NCT03104010 (ClinicalTrials.gov) | April 2017 | 28/3/2017 | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Somatropin Injection | GeneScience Pharmaceuticals Co., Ltd. | Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | China |
| 79 | NCT03145831 (ClinicalTrials.gov) | March 31, 2017 | 5/4/2017 | A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency | An Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somavaratan | Versartis Inc. | NULL | Terminated | 3 Years | N/A | All | 21 | Phase 3 | United States;Japan |
| 80 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 81 | EUCTR2016-001145-11-GR (EUCTR) | 28/03/2017 | 02/02/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 82 | NCT03075644 (ClinicalTrials.gov) | March 3, 2017 | 28/2/2017 | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 62 | Phase 3 | Japan |
| 83 | NCT03290235 (ClinicalTrials.gov) | March 1, 2017 | 19/9/2017 | Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | Growth Retardation | Drug: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 42 Months | 15 Years | All | 1500 | Phase 4 | China |
| 84 | JPRN-UMIN000027260 | 2017/02/06 | 07/05/2017 | Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading | Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons. | Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutes | Osaka City University Graduate School of Medicine | NULL | 2years-old | 15years-old | Male and Female | 15 | Not selected | Japan | ||
| 85 | EUCTR2016-002780-34-PL (EUCTR) | 30/01/2017 | 08/11/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan Product Code: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Canada;Belgium;Poland;Sweden | ||
| 86 | EUCTR2016-002780-34-BE (EUCTR) | 16/12/2016 | 19/09/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan Product Code: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Canada;Poland;Belgium;Sweden | ||
| 87 | NCT02781727 (ClinicalTrials.gov) | December 13, 2016 | 19/5/2016 | A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases | Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin | Ascendis Pharma Endocrinology Division A/S | NULL | Completed | 3 Years | 12 Years | All | 161 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine |
| 88 | NCT02968004 (ClinicalTrials.gov) | December 2016 | 13/11/2016 | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 224 | Phase 3 | United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey |
| 89 | EUCTR2016-002780-34-SE (EUCTR) | 10/11/2016 | 13/09/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone DeficiencyThe VISTA Study: Versartis Long-Term Safety Study of Somavaratan | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan Product Code: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Canada;Poland;Belgium;Sweden | ||
| 90 | EUCTR2015-001939-21-LV (EUCTR) | 15/08/2016 | 31/05/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 91 | NCT03015909 (ClinicalTrials.gov) | August 11, 2016 | 10/11/2016 | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. | A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device | Short Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner Syndrome | Drug: Somatropin | LG Life Sciences | NULL | Completed | 4 Years | 15 Years | All | 116 | Phase 4 | Korea, Republic of |
| 92 | NCT03203356 (ClinicalTrials.gov) | May 30, 2016 | 26/5/2017 | Adrenal Function in GHD Children | Evaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH Deficiency | Growth Hormone Treatment;Adrenal; Functional Disturbance | Drug: growth hormone | University of Palermo | NULL | Completed | 5 Years | 12 Years | All | 30 | N/A | Italy |
| 93 | EUCTR2015-002337-22-IT (EUCTR) | 24/05/2016 | 08/06/2021 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: Macimorelin acetate Trade Name: Humalog Mix50 100 U/ml sospensione iniettabile Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: Insulin | AETERNA ZENTARIS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 94 | EUCTR2015-001939-21-LT (EUCTR) | 04/05/2016 | 29/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 95 | EUCTR2015-001939-21-PL (EUCTR) | 19/04/2016 | 18/01/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of | ||
| 96 | EUCTR2015-002337-22-PL (EUCTR) | 12/04/2016 | 01/02/2016 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom | ||
| 97 | EUCTR2015-001939-21-EE (EUCTR) | 30/03/2016 | 16/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 98 | NCT02616562 (ClinicalTrials.gov) | March 23, 2016 | 25/11/2015 | Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® FlexPro® pen | Novo Nordisk A/S | NULL | Recruiting | N/A | 17 Years | All | 74 | Phase 2 | United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine |
| 99 | EUCTR2015-000531-32-DE (EUCTR) | 14/03/2016 | 20/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 100 | NCT03223025 (ClinicalTrials.gov) | March 9, 2016 | 18/7/2017 | Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency | Efficacy and Safety of CinnaGen Recombinant Human Growth Hormone (CinnaTropin®) in Comparison With Novo Nordisk Growth Hormone (Nordilet®) Product in Pre-Pubertal Children With Idiopathic Growth Hormone Deficiency (IGHD) | Idiopathic Growth Hormone Deficiency | Drug: CinnaTropin®;Drug: Nordilet® | Cinnagen | NULL | Completed | 4 Years | 16 Years | All | 30 | Phase 3 | NULL |
| 101 | EUCTR2014-004525-41-PL (EUCTR) | 09/03/2016 | 23/02/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH. | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Belgium;Poland;Netherlands;Sweden | ||
| 102 | EUCTR2015-000531-32-BE (EUCTR) | 17/02/2016 | 30/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Canada;Belgium;Brazil;Germany;Japan;Sweden | ||
| 103 | NCT02719990 (ClinicalTrials.gov) | February 9, 2016 | 16/3/2016 | Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD | An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD) | Adult Growth Hormone Deficiency (AGHD) | Drug: somavaratan | Versartis Inc. | Premier Research Group plc | Terminated | 18 Years | 75 Years | All | 34 | Phase 2 | Australia;United States |
| 104 | EUCTR2015-002337-22-DE (EUCTR) | 19/01/2016 | 09/11/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 105 | NCT03309891 (ClinicalTrials.gov) | January 18, 2016 | 5/9/2017 | Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency | A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Ukraine |
| 106 | EUCTR2015-000531-32-SE (EUCTR) | 14/01/2016 | 04/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 107 | EUCTR2014-003796-32-PL (EUCTR) | 08/01/2016 | 29/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Lithuania;Austria;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany | ||
| 108 | EUCTR2014-002736-13-PL (EUCTR) | 08/01/2016 | 29/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 109 | EUCTR2015-000531-32-SI (EUCTR) | 15/12/2015 | 11/11/2015 | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 110 | EUCTR2015-000531-32-AT (EUCTR) | 10/12/2015 | 03/11/2015 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | ||
| 111 | EUCTR2015-002337-22-AT (EUCTR) | 10/12/2015 | 30/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 112 | EUCTR2014-002736-13-HR (EUCTR) | 09/12/2015 | 01/02/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 113 | EUCTR2015-002337-22-GB (EUCTR) | 08/12/2015 | 28/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 114 | EUCTR2014-003796-32-HR (EUCTR) | 04/12/2015 | 01/02/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 115 | NCT02558829 (ClinicalTrials.gov) | December 3, 2015 | 21/9/2015 | Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT) | Growth Hormone Deficiency With Pituitary Anomalies | Drug: Macimorelin;Drug: Insulin | AEterna Zentaris | NULL | Completed | 18 Years | 65 Years | All | 157 | Phase 3 | United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom |
| 116 | EUCTR2014-003796-32-RO (EUCTR) | 18/11/2015 | 08/10/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 117 | EUCTR2015-001939-21-GR (EUCTR) | 12/11/2015 | 13/10/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia | ||
| 118 | EUCTR2015-001939-21-SK (EUCTR) | 22/10/2015 | 27/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 119 | EUCTR2015-002072-24-DE (EUCTR) | 22/10/2015 | 12/08/2015 | A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose. | An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD)Versartis International Trial in Adults with Long Acting Growth Hormone. The VITAL study - Versartis International Trial in Adults with Long Acting Growth Hormone (VITAL) | Growth Hormone Deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan Product Code: VRS-317 INN or Proposed INN: Somavaratan Other descriptive name: VRS-317 | Versartis Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Australia;Germany;United Kingdom | ||
| 120 | EUCTR2014-003796-32-SI (EUCTR) | 15/10/2015 | 12/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 121 | EUCTR2014-002736-13-SI (EUCTR) | 15/10/2015 | 12/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 122 | EUCTR2015-001939-21-CZ (EUCTR) | 14/10/2015 | 10/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 123 | EUCTR2013-002892-16-LV (EUCTR) | 12/10/2015 | 31/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden | ||
| 124 | EUCTR2005-000384-26-FR (EUCTR) | 12/10/2015 | 04/10/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 125 | EUCTR2014-003796-32-BG (EUCTR) | 07/10/2015 | 02/10/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 126 | EUCTR2014-003796-32-CZ (EUCTR) | 01/10/2015 | 14/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 127 | EUCTR2014-002736-13-CZ (EUCTR) | 01/10/2015 | 10/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 128 | EUCTR2013-002892-16-LT (EUCTR) | 30/09/2015 | 27/07/2015 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 129 | EUCTR2014-004525-41-NL (EUCTR) | 03/09/2015 | 23/03/2015 | A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH. | Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 130 | EUCTR2014-002736-13-IT (EUCTR) | 25/08/2015 | 27/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 131 | EUCTR2014-003796-32-IT (EUCTR) | 25/08/2015 | 27/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 132 | NCT02339090 (ClinicalTrials.gov) | August 24, 2015 | 7/1/2015 | Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency. | Growth Disorders | Drug: somavaratan;Drug: Daily rhGH | Versartis Inc. | NULL | Completed | 3 Years | 11 Years | All | 136 | Phase 3 | Belgium;Canada;Netherlands;Poland;Sweden;United States |
| 133 | EUCTR2014-003796-32-DE (EUCTR) | 21/08/2015 | 16/03/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 134 | EUCTR2014-002736-13-LT (EUCTR) | 20/08/2015 | 14/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 135 | EUCTR2014-003796-32-LT (EUCTR) | 20/08/2015 | 14/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 136 | EUCTR2014-002736-13-DE (EUCTR) | 19/08/2015 | 13/03/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 137 | NCT02413138 (ClinicalTrials.gov) | August 8, 2015 | 23/3/2015 | Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317) | A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) | Pediatric Growth Hormone Deficiency;Growth Disorders | Drug: Somavaratan (VRS-317) | Versartis Inc. | NULL | Terminated | 3 Years | 10 Years | All | 41 | Phase 2/Phase 3 | Japan |
| 138 | EUCTR2014-003796-32-ES (EUCTR) | 31/07/2015 | 08/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 139 | EUCTR2014-002736-13-ES (EUCTR) | 24/07/2015 | 08/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 140 | EUCTR2015-001939-21-HU (EUCTR) | 16/07/2015 | 22/05/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 141 | NCT02526420 (ClinicalTrials.gov) | July 2015 | 13/8/2015 | Versartis International Trial in Adults With Long-Acting Growth Hormone | An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD) | Adult Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | Premier Research Group plc | Completed | 23 Years | 70 Years | Both | 36 | Phase 2 | United States;Australia;Germany;United Kingdom |
| 142 | EUCTR2014-002698-13-PL (EUCTR) | 30/06/2015 | 22/05/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 143 | EUCTR2014-002736-13-HU (EUCTR) | 26/06/2015 | 10/04/2015 | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 144 | EUCTR2014-002736-13-GR (EUCTR) | 26/06/2015 | 10/06/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden;Lithuania;Austria;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey | ||
| 145 | EUCTR2014-003796-32-HU (EUCTR) | 26/06/2015 | 10/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 146 | EUCTR2014-003796-32-GR (EUCTR) | 22/06/2015 | 15/06/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 147 | EUCTR2014-003796-32-AT (EUCTR) | 22/06/2015 | 29/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 148 | EUCTR2014-002736-13-AT (EUCTR) | 22/06/2015 | 04/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 149 | EUCTR2014-002698-13-DE (EUCTR) | 11/06/2015 | 23/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 150 | EUCTR2013-004468-69-PL (EUCTR) | 28/05/2015 | 05/02/2015 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 151 | EUCTR2014-002736-13-SE (EUCTR) | 25/05/2015 | 21/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 152 | EUCTR2014-002736-13-SK (EUCTR) | 20/05/2015 | 15/01/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 153 | EUCTR2014-003796-32-SK (EUCTR) | 20/05/2015 | 15/01/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 154 | NCT02410343 (ClinicalTrials.gov) | April 30, 2015 | 30/3/2015 | Study of TV-1106 in Growth Hormone-Deficient Adults | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment | Growth Hormone Deficiency | Drug: TV-1106;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 3 | Hungary;Italy;Russian Federation;United States;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Serbia;Slovakia;Slovenia;Spain;Turkey;Ukraine;Austria;Czechia;Greece |
| 155 | NCT02410356 (ClinicalTrials.gov) | April 30, 2015 | 30/3/2015 | A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency | A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency | Growth Hormone Deficiency | Drug: TV-1106;Drug: dGH | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | 18 Years | N/A | All | 34 | Phase 3 | United States;Austria;Czechia;Greece;Hungary;Italy;Slovakia;Spain;Argentina;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey;Ukraine |
| 156 | EUCTR2014-004525-41-BE (EUCTR) | 22/04/2015 | 16/02/2015 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 157 | EUCTR2014-004525-41-SE (EUCTR) | 10/04/2015 | 12/02/2015 | A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan (VRS-317) INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinat human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 158 | NCT02311894 (ClinicalTrials.gov) | March 31, 2015 | 4/12/2014 | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency | A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY) | Growth Hormone Deficiency | Drug: Somatropin | Genentech, Inc. | NULL | Completed | 3 Years | 14 Years | All | 82 | Phase 4 | United States |
| 159 | EUCTR2014-002698-13-GR (EUCTR) | 26/02/2015 | 17/03/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 160 | EUCTR2013-004468-69-BG (EUCTR) | 18/02/2015 | 07/10/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 161 | EUCTR2014-002698-13-HU (EUCTR) | 17/02/2015 | 15/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 162 | NCT02382939 (ClinicalTrials.gov) | February 12, 2015 | 10/2/2015 | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency;Growth Hormone Disorder | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 79 Years | All | 92 | Phase 3 | Denmark;France;Germany;Japan;Sweden;United Kingdom |
| 163 | EUCTR2014-002698-13-SE (EUCTR) | 03/02/2015 | 18/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 164 | EUCTR2014-000290-39-GB (EUCTR) | 30/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | European Union;Denmark;Japan;United Kingdom;Sweden | ||
| 165 | EUCTR2014-000290-39-DK (EUCTR) | 22/01/2015 | 22/01/2015 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Sweden;Japan;United Kingdom;Denmark;European Union | |||
| 166 | EUCTR2013-004468-69-ES (EUCTR) | 22/01/2015 | 03/11/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 167 | EUCTR2014-002698-13-SK (EUCTR) | 14/01/2015 | 09/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 168 | NCT03249480 (ClinicalTrials.gov) | January 2015 | 24/7/2017 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 169 | NCT02976675 (ClinicalTrials.gov) | January 2015 | 24/11/2016 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong University | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China |
| 170 | NCT02946606 (ClinicalTrials.gov) | January 2015 | 28/8/2015 | A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 | A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | NULL | Completed | 20 Years | 65 Years | All | 45 | Phase 2 | Korea, Republic of |
| 171 | NCT02418767 (ClinicalTrials.gov) | January 2015 | 8/1/2015 | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Placebo | OPKO Health, Inc. | WCCT Global | Completed | 18 Years | 45 Years | Male | 42 | Phase 1 | United States |
| 172 | EUCTR2013-002892-16-DE (EUCTR) | 22/12/2014 | 29/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 173 | NCT02380235 (ClinicalTrials.gov) | December 2014 | 2/3/2015 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China | |
| 174 | EUCTR2013-002892-16-GB (EUCTR) | 20/11/2014 | 24/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 175 | EUCTR2014-000290-39-SE (EUCTR) | 07/11/2014 | 07/10/2014 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | |||
| 176 | NCT02908958 (ClinicalTrials.gov) | November 2014 | 19/9/2016 | Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency | Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 177 | NCT02314676 (ClinicalTrials.gov) | November 2014 | 27/11/2014 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Dwarfism, Pituitary | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | NULL | Recruiting | 3 Years | N/A | Both | 900 | Phase 4 | China | |
| 178 | NCT02229851 (ClinicalTrials.gov) | October 31, 2014 | 26/8/2014 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 23 Years | 79 Years | All | 301 | Phase 3 | United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom |
| 179 | EUCTR2013-002892-16-SE (EUCTR) | 07/10/2014 | 03/09/2014 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml INN or Proposed INN: N/A Other descriptive name: NNC0195-0092 Trade Name: Norditropin FlexPro 10 mg INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | ||
| 180 | NCT02243852 (ClinicalTrials.gov) | September 2014 | 16/9/2014 | Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) | Evaluation of the Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) Concentration in Patients With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: Growth Hormone Replacement Therapy | University of Liverpool | Pfizer | Recruiting | 18 Years | 80 Years | Both | 48 | N/A | United Kingdom |
| 181 | EUCTR2013-004468-69-CZ (EUCTR) | 08/08/2014 | 11/04/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 182 | EUCTR2013-004468-69-GR (EUCTR) | 29/07/2014 | 16/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 183 | NCT02018172 (ClinicalTrials.gov) | July 2014 | 17/12/2013 | Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device | Growth Hormone Deficiency;Turner's Syndrome | Drug: somatropin | Ferring Pharmaceuticals | NULL | Terminated | N/A | N/A | Both | 3 | N/A | France | |
| 184 | EUCTR2013-000830-37-PL (EUCTR) | 11/06/2014 | 03/01/2014 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 185 | EUCTR2013-004468-69-HU (EUCTR) | 11/06/2014 | 21/02/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia | ||
| 186 | NCT02092077 (ClinicalTrials.gov) | April 30, 2014 | 14/3/2014 | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth Hormone-Deficiency | Drug: TV-1106;Drug: somatropin | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 3 Years | 11 Years | All | 65 | Phase 2 | Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia |
| 187 | NCT02068521 (ClinicalTrials.gov) | March 3, 2014 | 6/2/2014 | Versartis Long-Term Safety Study of Somavaratan | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | NULL | Terminated | 3 Years | N/A | All | 385 | Phase 2/Phase 3 | United States |
| 188 | EUCTR2011-001826-61-BG (EUCTR) | 07/02/2014 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 189 | EUCTR2013-000013-20-ES (EUCTR) | 02/01/2014 | 10/01/2014 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Belgium;Spain;Austria;Israel;Norway;Switzerland;Sweden | ||
| 190 | EUCTR2013-000830-37-NL (EUCTR) | 02/01/2014 | 29/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 191 | NCT02507245 (ClinicalTrials.gov) | January 2014 | 3/6/2015 | Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD) | Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD) | Growth Hormone Deficiency | Drug: Growth Hormone-Releasing Hormone | Stefania La Grutta, MD | NULL | Completed | 5 Years | 15 Years | Both | 48 | N/A | NULL |
| 192 | EUCTR2013-000013-20-SE (EUCTR) | 20/12/2013 | 12/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 193 | EUCTR2013-000013-20-BE (EUCTR) | 17/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 194 | EUCTR2013-000013-20-AT (EUCTR) | 16/12/2013 | 11/12/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 195 | NCT01973244 (ClinicalTrials.gov) | December 16, 2013 | 22/10/2013 | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 13 Years | All | 32 | Phase 1 | Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland |
| 196 | EUCTR2013-000013-20-SI (EUCTR) | 09/12/2013 | 20/09/2013 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 197 | EUCTR2013-000830-37-ES (EUCTR) | 12/10/2013 | 12/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 198 | EUCTR2013-000830-37-GB (EUCTR) | 30/09/2013 | 09/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Armenia;Poland;Romania;Australia;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 199 | EUCTR2013-000830-37-GR (EUCTR) | 12/09/2013 | 03/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Romania;Germany;Netherlands | ||
| 200 | EUCTR2012-002787-27-BG (EUCTR) | 11/09/2013 | 03/06/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany | ||
| 201 | EUCTR2012-004975-37-SE (EUCTR) | 05/09/2013 | 09/07/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden | ||
| 202 | EUCTR2013-000830-37-SK (EUCTR) | 04/09/2013 | 24/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 203 | EUCTR2013-000830-37-AT (EUCTR) | 29/08/2013 | 11/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 204 | EUCTR2012-004975-37-DE (EUCTR) | 05/08/2013 | 02/05/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 205 | EUCTR2012-002787-27-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 206 | EUCTR2013-000830-37-HU (EUCTR) | 03/07/2013 | 23/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 207 | NCT01947907 (ClinicalTrials.gov) | July 2013 | 3/6/2013 | Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: ACP-001;Drug: Human Growth Hormone | Ascendis Pharma A/S | NULL | Completed | 3 Years | 12 Years | All | 53 | Phase 2 | Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine |
| 208 | EUCTR2012-004975-37-CZ (EUCTR) | 20/06/2013 | 04/01/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 209 | EUCTR2012-002787-27-DE (EUCTR) | 17/06/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 210 | NCT01909479 (ClinicalTrials.gov) | June 2013 | 24/7/2013 | A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting Hgh Product (Mod-4023) In Adult Subjects With Growth Hormone Deficiency | A PHASE 3, MULTICENTER STUDY DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF A LONG ACTING HGH PRODUCT (MOD-4023) IN ADULT SUBJECTS WITH GROWTH HORMONE DEFICIENCY | Adult Growth Hormone Deficiency | Drug: MOD-4023;Other: Placebo | OPKO Health, Inc. | NULL | Terminated | 23 Years | 70 Years | All | 189 | Phase 3 | Israel;United States |
| 211 | NCT01806298 (ClinicalTrials.gov) | June 2013 | 5/3/2013 | An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) | Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Saizen® solution for injection (referred as Saizen®) | Merck KGaA | NULL | Completed | 18 Years | 65 Years | All | 78 | Phase 4 | Australia;Germany;Sweden;United Kingdom;Czech Republic |
| 212 | EUCTR2012-004975-37-SI (EUCTR) | 22/05/2013 | 17/04/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden | ||
| 213 | EUCTR2012-005066-36-NL (EUCTR) | 15/05/2013 | 23/01/2013 | To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency | Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors | Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Genotropin Trade Name: Norditropin Trade Name: Humatrope Trade Name: Zomacton | VU University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 214 | EUCTR2012-004263-47-CZ (EUCTR) | 13/05/2013 | 05/03/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 215 | EUCTR2012-002787-27-CZ (EUCTR) | 10/05/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 216 | NCT01877512 (ClinicalTrials.gov) | May 2013 | 11/6/2013 | GH and Cardiovascular Risk Factors | Effect of Growth Hormone Replacement Therapy on Cardiovascular Risk Factors in Adult Patients With Severe Growth Hormone Deficiency: Association With IGF-I Concentration | Growth Hormone Deficiency;Cardiovascular Diseases;Metabolic Syndrome;Cognition;Physical Activity | Drug: Change in daily dosage of Growth Hormone | VU University Medical Center | NULL | Completed | 20 Years | 65 Years | Both | 32 | Phase 4 | Netherlands |
| 217 | EUCTR2012-004263-47-DE (EUCTR) | 03/04/2013 | 25/02/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 218 | EUCTR2011-004553-60-PL (EUCTR) | 02/04/2013 | 09/02/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 219 | NCT01811576 (ClinicalTrials.gov) | March 31, 2013 | 12/3/2013 | A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: TV-1106;Drug: Recombinant human growth hormone | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 23 Years | 65 Years | All | 52 | Phase 2 | United States;Czechia;Germany;Greece;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic;Sweden |
| 220 | EUCTR2012-004975-37-GR (EUCTR) | 27/03/2013 | 29/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden | ||
| 221 | EUCTR2012-004263-47-SE (EUCTR) | 06/03/2013 | 14/01/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 222 | EUCTR2012-002787-27-GR (EUCTR) | 04/03/2013 | 15/02/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 223 | EUCTR2012-004263-47-GB (EUCTR) | 01/03/2013 | 08/01/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 224 | NCT01494779 (ClinicalTrials.gov) | March 2013 | 28/11/2011 | Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A. | GH Deficiency (GHD);Growth Retardation | Drug: Somatropin | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | NULL | Not yet recruiting | 18 Years | 32 Years | Male | 32 | Phase 1 | Brazil | |
| 225 | EUCTR2012-004975-37-SK (EUCTR) | 27/02/2013 | 04/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 226 | EUCTR2012-002787-27-HU (EUCTR) | 11/02/2013 | 11/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 227 | NCT02500316 (ClinicalTrials.gov) | February 2013 | 12/7/2015 | Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children | Growth Hormone Deficiency (GHD) | Drug: MOD-4023 | OPKO Health, Inc. | NULL | Active, not recruiting | 3 Years | 11 Years | All | 48 | Phase 2 | United States;Belarus;Greece;Hungary;Russian Federation;Ukraine;Slovakia |
| 228 | EUCTR2012-004975-37-HU (EUCTR) | 21/01/2013 | 23/11/2012 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden | ||
| 229 | NCT01901666 (ClinicalTrials.gov) | January 2013 | 29/6/2013 | Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In Remission | ASSESSMENT OF GH-IGF1 AXIS AND TO STUDY RESPONSE TO GH THERAPY IN CHILDREN WITH CML IN REMISSION HAVING GH DEFICIENCY | Chronic Myelogenous Leukemia;Short Stature | Drug: Growth Hormone | Postgraduate Institute of Medical Education and Research | NULL | Recruiting | N/A | N/A | Both | 20 | Phase 4 | India |
| 230 | NCT01731028 (ClinicalTrials.gov) | January 2013 | 16/11/2012 | Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton® | Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice | Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | NULL | Withdrawn | 3 Years | 18 Years | Both | 0 | N/A | NULL |
| 231 | NCT01775358 (ClinicalTrials.gov) | January 2013 | 17/1/2013 | Phase 1 Safety Study of ALRN-5281 in Healthy Subjects | A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers | Growth Hormone Deficiency | Drug: ALRN-5281 0.015 mg/kg;Drug: ALRN-5281 0.05 mg/kg;Drug: ALRN-5281 0.15 mg/kg;Drug: Placebo 0.015 mg/kg;Drug: Placebo 0.05mg/kg;Drug: Placebo 0.15mg/kg | Aileron Therapeutics | NULL | Completed | 20 Years | 50 Years | Both | 33 | Phase 1 | United States |
| 232 | NCT01706783 (ClinicalTrials.gov) | October 12, 2012 | 11/10/2012 | A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin NordiFlex® | Novo Nordisk A/S | NULL | Completed | 20 Years | 70 Years | All | 35 | Phase 1 | Denmark;Sweden |
| 233 | NCT01718041 (ClinicalTrials.gov) | October 2012 | 19/10/2012 | Versartis Trial in Children to Assess Long-Acting Growth Hormone | A Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children With Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy After Subcutaneous Administration for 6 Months | Pediatric Growth Hormone Deficiency | Drug: Experimental: VRS-317 | Versartis Inc. | NULL | Completed | 3 Years | 11 Years | Both | 64 | Phase 1/Phase 2 | United States |
| 234 | EUCTR2011-005377-23-ES (EUCTR) | 18/07/2012 | 21/05/2012 | Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD). | A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). | Spinal Cord Injury and Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10041558;Term: Spinal cord injury thoracic;System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1;Classification code 10041554;Term: Spinal cord injury cervical;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Trade Name: NUTROPIN Product Name: NutropinAq 10 mg/2 ml (30 UI) INN or Proposed INN: SOMATROPIN | Guillem Cuatrecasas Cambra | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 235 | EUCTR2011-004553-60-BG (EUCTR) | 02/07/2012 | 10/04/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 236 | EUCTR2011-004553-60-CZ (EUCTR) | 10/04/2012 | 06/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 237 | NCT01592500 (ClinicalTrials.gov) | February 2012 | 2/5/2012 | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Greece;Hungary;Slovakia |
| 238 | EUCTR2011-001826-61-PL (EUCTR) | 25/01/2012 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 239 | EUCTR2011-004553-60-GR (EUCTR) | 23/01/2012 | 27/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel | |||
| 240 | NCT01514500 (ClinicalTrials.gov) | January 16, 2012 | 13/1/2012 | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;Healthy | Drug: somapacitan;Drug: placebo (somapacitan) | Novo Nordisk A/S | NULL | Completed | 20 Years | 45 Years | Male | 105 | Phase 1 | Germany |
| 241 | EUCTR2011-004553-60-SK (EUCTR) | 10/01/2012 | 24/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 242 | EUCTR2011-004553-60-HU (EUCTR) | 10/01/2012 | 03/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation | ||
| 243 | NCT01822340 (ClinicalTrials.gov) | October 2011 | 25/3/2013 | Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients | A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: HM10560A;Drug: Genotropin | Hanmi Pharmaceutical Company Limited | NULL | Completed | 23 Years | 60 Years | Both | 72 | Phase 2 | Hungary;Romania |
| 244 | NCT01440686 (ClinicalTrials.gov) | September 2011 | 23/9/2011 | Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers | A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | HanAll BioPharma Co., Ltd. | NULL | Completed | 19 Years | 50 Years | Male | 40 | Phase 1 | Korea, Republic of |
| 245 | EUCTR2011-000460-10-CZ (EUCTR) | 22/08/2011 | 22/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 246 | EUCTR2011-000460-10-ES (EUCTR) | 16/08/2011 | 21/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy power for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 247 | EUCTR2011-000460-10-GB (EUCTR) | 03/08/2011 | 17/05/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | idiopathic growth hormone deficientyTurner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: Saizen 8mg click.easy powder for solution for injection Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom | ||
| 248 | EUCTR2011-001826-61-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 249 | NCT01237041 (ClinicalTrials.gov) | July 1, 2011 | 6/11/2010 | Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children | Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children | Obesity;Short Stature;Growth Hormone Deficiency | Drug: Niacin First;Drug: Placebo First;Drug: Dose-Establishing Study 1 Niacin 250mg;Drug: Dose-Establishing Study 1 Niacin 500mg;Drug: Dose-Establishing Study 2 Niacin 500mg | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Terminated | 7 Years | 14 Years | All | 37 | Phase 1/Phase 2 | United States |
| 250 | EUCTR2010-020742-10-GB (EUCTR) | 09/05/2011 | 04/11/2010 | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 251 | EUCTR2010-020742-10-ES (EUCTR) | 01/04/2011 | 07/01/2011 | Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica | Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica | Niños pre-puberales con déficit idiopático de hormona de crecimiento MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable INN or Proposed INN: SOMATROPINA Other descriptive name: SOMATROPIN Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA Trade Name: INCRELEX 10 mg/ml, solución inyectable INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES INN or Proposed INN: MECASERMINA Other descriptive name: MECASERMINA | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Finland;United Kingdom;Spain;Sweden | |||
| 252 | NCT01327924 (ClinicalTrials.gov) | April 2011 | 31/3/2011 | Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone | Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Delivery Systems | Drug: Norditropin NordiFlex® | Novo Nordisk A/S | NULL | Completed | N/A | 16 Years | Both | 77 | N/A | France |
| 253 | EUCTR2010-023430-23-GB (EUCTR) | 28/03/2011 | 24/01/2011 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;Czech Republic;United Kingdom | |||
| 254 | NCT01359488 (ClinicalTrials.gov) | March 2011 | 13/5/2011 | VRS-317 in Adult Subjects With Growth Hormone Deficiency | A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: VRS-317 | Versartis Inc. | NULL | Completed | 25 Years | 65 Years | Both | 50 | Phase 1 | United States |
| 255 | NCT01804413 (ClinicalTrials.gov) | March 2011 | 18/2/2013 | Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency | Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study | Adults Growth Hormone Deficiency. | Drug: Pegvisomant;Drug: Regular insulin | Oregon Health and Science University | Aarhus University Hospital | Recruiting | 21 Years | 55 Years | Both | 10 | N/A | United States |
| 256 | EUCTR2010-020742-10-SE (EUCTR) | 23/02/2011 | 19/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 257 | EUCTR2010-019374-32-AT (EUCTR) | 15/02/2011 | 29/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany | ||
| 258 | EUCTR2010-023430-23-CZ (EUCTR) | 09/02/2011 | 25/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 259 | EUCTR2010-023430-23-HU (EUCTR) | 17/01/2011 | 10/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 260 | EUCTR2010-020742-10-FI (EUCTR) | 10/01/2011 | 22/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 261 | NCT01282164 (ClinicalTrials.gov) | January 2011 | 19/1/2011 | The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis | The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis | Adult Growth Hormone Deficiency;Hypothalamic-pituitary Disorders | Procedure: Glucagon stimulation test and insulin tolerance test;Procedure: glucagon stimulation test and insulin tolerance test | The Cleveland Clinic | Massachusetts General Hospital;Allegheny Endocrinology Associates;Oregon Health and Science University | Completed | 18 Years | 80 Years | All | 43 | N/A | United States |
| 262 | EUCTR2009-017354-12-GB (EUCTR) | 08/11/2010 | 18/06/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Netherlands;Germany;United Kingdom;Sweden | ||
| 263 | NCT01247675 (ClinicalTrials.gov) | November 2010 | 23/11/2010 | A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: ACP-001 (TransCon hGH);Drug: Omnitrope | Ascendis Pharma A/S | NULL | Completed | 20 Years | 70 Years | All | 37 | Phase 2 | Denmark;Germany;Italy;Sweden |
| 264 | NCT01243892 (ClinicalTrials.gov) | November 2010 | 17/11/2010 | A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device | A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin® | Growth Hormone Deficiency | Device: NuSpin;Drug: Somatropin | Genentech, Inc. | NULL | Terminated | 2 Years | 14 Years | All | 18 | Phase 4 | United States |
| 265 | EUCTR2009-017354-12-SE (EUCTR) | 11/10/2010 | 09/04/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Czech Republic;Sweden | |||
| 266 | EUCTR2010-021523-28-DE (EUCTR) | 05/10/2010 | 10/08/2010 | A study to investigate pharmacokinetic and short-term efficacy in adult patients with growth hormone deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 267 | NCT01237340 (ClinicalTrials.gov) | October 2010 | 5/11/2010 | Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study | A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: Saizen® | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 59 | Phase 3 | United States |
| 268 | NCT01090778 (ClinicalTrials.gov) | October 2010 | 22/3/2010 | Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) | Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Norditropin SimpleXx (growth hormone) | Aarhus University Hospital | Novo Nordisk A/S | Completed | 18 Years | 75 Years | Both | 8 | Phase 2 | Denmark |
| 269 | EUCTR2010-021523-28-IT (EUCTR) | 28/09/2010 | 27/12/2010 | A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND | A phase 2, multiple dose, open-label, parallel-group, active controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ACP-001 in adult patients with growth hormone deficiency (AGHD) - ND | Growth Hormone Deficiency MedDRA version: 9.1;Level: PT;Classification code 10056438 | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: OMNITROPE INN or Proposed INN: Somatropin | ASCENDIS PHARMA A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Germany;Denmark;Italy;Austria;Sweden | ||
| 270 | EUCTR2010-021523-28-SE (EUCTR) | 27/09/2010 | 06/08/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: Somatropin Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 271 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 272 | EUCTR2010-021523-28-DK (EUCTR) | 13/09/2010 | 29/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Austria;Denmark;Germany;Italy;Sweden | ||
| 273 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Omnitrop Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: ecombinanat DNA-derived human growth h | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 274 | EUCTR2010-019374-32-CZ (EUCTR) | 06/09/2010 | 15/06/2010 | A study with MOD-4023 in patients with lack of Growth Hormone in the body | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Prolor Biotech Ltd | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel | ||
| 275 | EUCTR2010-021523-28-AT (EUCTR) | 02/09/2010 | 20/07/2010 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: SOMATROPIN Trade Name: Omnitrope® INN or Proposed INN: SOMATROPIN | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | ||
| 276 | NCT01225666 (ClinicalTrials.gov) | August 2010 | 19/10/2010 | MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Adult Growth Hormone Deficiency | Drug: MOD-4023 | OPKO Health, Inc. | NULL | Completed | 23 Years | 60 Years | All | 52 | Phase 2 | Czechia;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic |
| 277 | EUCTR2009-017354-12-DE (EUCTR) | 29/07/2010 | 08/06/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Czech Republic;Germany;Sweden | |||
| 278 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 279 | EUCTR2009-017354-12-CZ (EUCTR) | 22/06/2010 | 14/04/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Czech Republic;Sweden | |||
| 280 | EUCTR2010-019735-35-FR (EUCTR) | 14/06/2010 | 30/04/2010 | Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien | Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien | Déficit somatotrope de l'adulte consécutif à un traumatisme crânien MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Nutropin Aq Product Name: NutropinAq | CHU Amiens | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 281 | EUCTR2009-017354-12-SK (EUCTR) | 09/06/2010 | 26/05/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Trade Name: Genotropin 5.3 mg in injection system Genotropin pen INN or Proposed INN: SOMATROPIN Other descriptive name: n/a Trade Name: Genotropin 12 mg INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Czech Republic;Slovakia;Germany;United Kingdom;Sweden | ||
| 282 | EUCTR2010-018586-39-DK (EUCTR) | 01/06/2010 | 12/05/2010 | Diurnal variation of exogenous peptides - Gh Puls/Jurgita I | Diurnal variation of exogenous peptides - Gh Puls/Jurgita I | Adults with growth hormone disease (AGHD). | Trade Name: Norditropin® SimpleXx® 5 mg/1.5ml Other descriptive name: GROWTH HORMONE | Medical Department M (Endocrinology & Diabetes) | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | Denmark | ||
| 283 | EUCTR2010-019296-30-GB (EUCTR) | 18/05/2010 | 16/04/2010 | A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1 | ALS (acid label subunit) deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth Hormone Deficiency | Trade Name: INCRELEX Product Name: Increlex | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 284 | NCT01613573 (ClinicalTrials.gov) | March 2010 | 1/6/2012 | Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children | A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children | Growth Hormone Deficiency | Drug: somatropin AQ;Drug: pegylated somatropin | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology | Completed | 4 Years | 10 Years | Male | 12 | Phase 1 | NULL |
| 285 | EUCTR2009-016783-37-SE (EUCTR) | 07/01/2010 | 16/10/2009 | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | Growth hormone deficiency in adults | Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 INN or Proposed INN: recombinant human growth hormone | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 286 | NCT00884000 (ClinicalTrials.gov) | January 2010 | 17/4/2009 | A Study of Zomacton in Children With Growth Hormone Deficiency | A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Genotropin;Drug: Zomacton | Ferring Pharmaceuticals | NULL | Completed | 3 Years | 11 Years | Both | 165 | Phase 3 | Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine |
| 287 | NCT01605331 (ClinicalTrials.gov) | December 2009 | 22/5/2012 | Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) | Growth Hormone Deficiency | Drug: sustained-release recombinant human GH (SR-rhGH) | LG Life Sciences | NULL | Completed | 20 Years | N/A | Both | 132 | Phase 4 | NULL | |
| 288 | EUCTR2008-008240-25-ES (EUCTR) | 04/11/2009 | 10/08/2009 | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Ensayo aleatorizado, abierto, de dosis única y escalada de dosis para investigar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de la hormona de crecimiento humana pegilada de acción prolongada (NNC126-0083) en comparación con Norditropin NordiFlex® en niños con déficit de hormona de crecimientoA randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | Déficit de hormona de crecimientogrowth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Slovenia;Belgium;Spain;Denmark;United Kingdom | ||
| 289 | NCT01007071 (ClinicalTrials.gov) | November 1, 2009 | 30/10/2009 | Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency | Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults | Hypopituitarism | Drug: Human Growth Hormone (1-134);Drug: Placebo | Stanford University | Genentech, Inc. | Completed | 18 Years | 65 Years | All | 11 | Phase 3 | United States |
| 290 | EUCTR2008-008240-25-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Slovenia;Denmark;France;Spain | |||
| 291 | EUCTR2008-008240-25-GB (EUCTR) | 01/10/2009 | 18/06/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 292 | NCT01109017 (ClinicalTrials.gov) | October 2009 | 19/4/2010 | Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency | A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 387 | N/A | Japan |
| 293 | EUCTR2008-008240-25-FR (EUCTR) | 02/09/2009 | 10/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | ||
| 294 | EUCTR2009-010918-30-IE (EUCTR) | 11/08/2009 | 11/03/2009 | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care. MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign | Trade Name: Genotropin 5.3mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin 12mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.4mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.6mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.8mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.0mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniqu | Amar Agha, Beaumont Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Ireland | |||
| 295 | NCT00936403 (ClinicalTrials.gov) | August 2009 | 9/7/2009 | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: NNC126-0083;Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 6 Years | 12 Years | All | 31 | Phase 2 | Belgium;Czech Republic;Denmark;France;Israel;Macedonia, The Former Yugoslav Republic of;Slovenia;Spain;Turkey;United Kingdom |
| 296 | EUCTR2008-004849-28-HU (EUCTR) | 09/07/2009 | 03/06/2009 | A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency - | Idiopathic growth hormone deficiency. MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Zomacton 10 mg/ml INN or Proposed INN: Somatropin Trade Name: Genotropin 12 mg/ml INN or Proposed INN: Somatropin | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 138 | Hungary | ||||
| 297 | NCT00934063 (ClinicalTrials.gov) | July 2009 | 2/7/2009 | An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® | A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin) | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Other: No treatment given | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | Both | 121 | N/A | Germany |
| 298 | EUCTR2008-008240-25-BE (EUCTR) | 10/06/2009 | 24/04/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | France;Slovenia;Spain;Belgium;Denmark;United Kingdom | |||
| 299 | EUCTR2008-008240-25-SI (EUCTR) | 25/05/2009 | 06/05/2009 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: NNC 126-0083 Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A INN or Proposed INN: Somatropin | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Denmark;Slovenia;France;Spain | |||
| 300 | EUCTR2008-001674-32-FI (EUCTR) | 29/04/2009 | 25/08/2008 | NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS | NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS | Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency MedDRA version: 16.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders | Trade Name: Norditropin INN or Proposed INN: somatotropine | Novo Nordisk Farma Oy | NULL | Not Recruiting | Female: yes Male: yes | 17000 | Phase 4 | Finland | ||
| 301 | NCT00837863 (ClinicalTrials.gov) | March 2009 | 2/2/2009 | Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency | A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Altus Pharmaceuticals | NULL | Recruiting | 3 Years | 13 Years | Both | 36 | Phase 2 | United States |
| 302 | NCT01298180 (ClinicalTrials.gov) | January 2009 | 6/11/2009 | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Prader-Willi Syndrome;Growth Hormone Deficiency | Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsy | University Hospital, Toulouse | NULL | Completed | 1 Year | 5 Years | All | 111 | Phase 4 | France |
| 303 | EUCTR2007-001746-40-HU (EUCTR) | 25/08/2008 | 02/04/2007 | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: ARX201 Other descriptive name: Pegylated recombinant human growth hormone | Ambrx, Inc., USA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Hungary | ||
| 304 | NCT00778518 (ClinicalTrials.gov) | July 2008 | 22/10/2008 | Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD). | Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD). | Growth Hormone Deficiency | Drug: ARX201 | Ambrx, Inc. | Merck Serono International SA | Completed | 18 Years | 30 Years | Male | 36 | Phase 2 | Hungary |
| 305 | NCT00715689 (ClinicalTrials.gov) | July 2008 | 14/7/2008 | Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 | Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: NNC126-0083;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 20 Years | 65 Years | All | 33 | Phase 2 | Denmark |
| 306 | NCT00675506 (ClinicalTrials.gov) | July 2008 | 7/5/2008 | Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese | Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity | Abdominal Obesity;Growth Hormone Deficiency | Drug: Growth hormone releasing hormone (GHRH) 1-44;Drug: Placebo | Massachusetts General Hospital | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 55 Years | All | 60 | Phase 2 | United States |
| 307 | EUCTR2008-001061-29-DK (EUCTR) | 17/06/2008 | 29/04/2008 | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | Growth hormone deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: NN8630 Product Code: NNC 126-0083 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 32 | Denmark | |||
| 308 | NCT00630487 (ClinicalTrials.gov) | May 2008 | 28/2/2008 | Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency | Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study) | Growth Hormone Deficiency | Drug: Placebo;Drug: Somatropin | Pfizer | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 3 | Germany |
| 309 | EUCTR2007-003586-41-IT (EUCTR) | 04/03/2008 | 01/07/2008 | PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND | PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - ND | Growth hormone deficiency (GHD)after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | |||
| 310 | NCT00555009 (ClinicalTrials.gov) | March 2008 | 24/10/2007 | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury | Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury. | Brain Injuries;Growth Hormone Deficiency | Drug: Genotropin;Drug: Placebo | Pfizer | NULL | Terminated | 18 Years | 55 Years | All | 10 | Phase 4 | France;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 311 | NCT00646815 (ClinicalTrials.gov) | March 2008 | 19/2/2008 | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (genotropin) | University of Aarhus | Aarhus University Hospital | Completed | 18 Years | 60 Years | Both | 24 | N/A | Denmark |
| 312 | EUCTR2007-003586-41-FR (EUCTR) | 13/02/2008 | 14/11/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin/GENOTONORM® Product Name: Genotropin/GENOTONORM® | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | |||
| 313 | EUCTR2007-000790-36-DE (EUCTR) | 08/01/2008 | 12/12/2007 | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Isolated Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin 5 mg/ml INN or Proposed INN: Somatropin Trade Name: Genotropin 5 mg/ml INN or Proposed INN: Somatropin | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 314 | NCT00684957 (ClinicalTrials.gov) | January 2008 | 23/5/2008 | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1 | Columbia University | Tercica | Terminated | 25 Years | 65 Years | Male | 5 | N/A | United States |
| 315 | EUCTR2007-003586-41-NL (EUCTR) | 17/12/2007 | 09/08/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin Product Name: Genotropin | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | |||
| 316 | NCT01365351 (ClinicalTrials.gov) | December 1, 2007 | 1/6/2011 | Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON | Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Other: Growth hormone | Ferring Pharmaceuticals | Ferring Arzneimittel GmbH | Completed | N/A | N/A | All | 1034 | N/A | Germany |
| 317 | EUCTR2005-005587-82-GR (EUCTR) | 28/11/2007 | 28/06/2007 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of PHA-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 318 | EUCTR2007-003586-41-ES (EUCTR) | 26/11/2007 | 20/11/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injuryEnsayo controlado con placebo sobre la eficacia del tratamiento de reposición de hormona de crecimiento en pacientes con déficit de hormona de crecimiento después de un traumatismo cerebral. - N/A | Tratamiento del déficit de hormona de crecimiento en adultos después de un traumatismo cerebral. MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (Marca internacional Genotropin) Product Name: Genotonorm Kabipen 5.3 mg polvo y disolvente para sol. inyectable (Marca internacional Genotropin) INN or Proposed INN: Somatropina | Pfizer, S.A | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Spain;Netherlands;Italy;United Kingdom;Sweden | ||
| 319 | EUCTR2007-003586-41-SE (EUCTR) | 21/11/2007 | 12/09/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin Product Name: Genotropin | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | |||
| 320 | EUCTR2007-003586-41-GB (EUCTR) | 15/11/2007 | 11/10/2007 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A | Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Genotropin Product Name: Genotropin | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | |||
| 321 | NCT01306357 (ClinicalTrials.gov) | September 2007 | 28/2/2011 | Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device | Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective | Turner's Syndrome;Human Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | NULL | Completed | N/A | N/A | Both | 87 | N/A | France |
| 322 | EUCTR2006-003678-82-NL (EUCTR) | 10/07/2007 | 02/04/2008 | Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency | Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency | Clonidine is studied in the paediatric population, more specific children with short stature. It is used as a diagnostic tool to establish Growth Hormone reserve in routine practice. MedDRA version: 8.1;Level: LLT;Classification code 10005573;Term: Blood growth hormone decreased | Trade Name: Catapresan | Centre for Human Drug Research | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 323 | EUCTR2005-005587-82-PL (EUCTR) | 07/07/2007 | 31/05/2007 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Czech Republic;Greece;Belgium;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 324 | NCT00491582 (ClinicalTrials.gov) | July 2007 | 25/6/2007 | The Effects of Growth Hormone (GH) on Lipid Depots | The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance | Growth Hormone Deficiency | Drug: Growth hormone replacement therapy in growth hormone deficient patients only. | University Hospital Inselspital, Berne | Swiss National Science Foundation | Completed | 18 Years | 80 Years | Both | 34 | N/A | Switzerland |
| 325 | NCT00324064 (ClinicalTrials.gov) | July 2007 | 8/5/2006 | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Growth Hormone Deficiency | Procedure: GHRH/arginine stimulation testing | Children's Mercy Hospital Kansas City | NULL | Completed | 5 Years | 40 Years | Both | 90 | N/A | United States |
| 326 | NCT00448747 (ClinicalTrials.gov) | June 2007 | 16/3/2007 | Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test. | A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy | Diagnosis of Adult Growth Hormone Deficiency (AGDH) | Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRH | AEterna Zentaris | NULL | Completed | 18 Years | N/A | All | 101 | Phase 3 | United States |
| 327 | EUCTR2006-002278-24-SE (EUCTR) | 15/05/2007 | 05/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 328 | EUCTR2006-002278-24-GB (EUCTR) | 02/05/2007 | 23/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 329 | NCT00615953 (ClinicalTrials.gov) | May 2007 | 3/2/2008 | American Norditropin Studies - Registry of Growth Hormone (GH) Patients | American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149 | Growth Hormone Deficiency | Drug: Norditropin Growth Hormone | Duke University | Novo Nordisk A/S | Suspended | N/A | N/A | Both | 79 | N/A | United States |
| 330 | EUCTR2006-002278-24-SK (EUCTR) | 20/04/2007 | 22/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 331 | EUCTR2006-002278-24-FR (EUCTR) | 13/04/2007 | 24/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 332 | EUCTR2006-002278-24-IT (EUCTR) | 05/04/2007 | 16/12/2008 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | Growth hormone deficiency MedDRA version: 9.1;Level: HLT;Classification code 10002701;Term: Anterior pituitary hypofunction | Product Name: LB03002 INN or Proposed INN: sustained release growth hormone | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 333 | NCT00455260 (ClinicalTrials.gov) | April 2007 | 2/4/2007 | A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ System | Teva Neuroscience, Inc. | Teva Pharmaceutical Industries;TransPharma Medical | Completed | 20 Years | 60 Years | Both | 60 | Phase 1 | Israel;Ukraine |
| 334 | NCT00432263 (ClinicalTrials.gov) | April 2007 | 5/2/2007 | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury. | Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury | Brain Injuries | Drug: Genotropin (PN-180,307) Somatropin | Pfizer | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 4 | NULL |
| 335 | NCT01495468 (ClinicalTrials.gov) | March 2007 | 16/12/2011 | Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical Trial | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin University | Completed | 8 Years | 15 Years | All | 343 | Phase 3 | China |
| 336 | NCT01187550 (ClinicalTrials.gov) | March 2007 | 22/8/2010 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary | Drug: Recombinant human growth hormone (r-hGH) | Merck KGaA | Merck Serono Co., Ltd., China | Completed | N/A | N/A | All | 214 | Phase 4 | NULL |
| 337 | NCT00601419 (ClinicalTrials.gov) | March 2007 | 15/1/2008 | Drug Use Investigation of Somatropin for GHD-ADULTS. | Drug Use Investigation of GENOTROPIN for GHD-ADULTS. | Dwarfism, Growth Hormone Deficiency | Drug: Somatropin | Pfizer | NULL | Completed | N/A | N/A | All | 230 | N/A | NULL |
| 338 | EUCTR2005-005587-82-CZ (EUCTR) | 15/02/2007 | 25/10/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 339 | NCT00720902 (ClinicalTrials.gov) | February 2007 | 16/6/2008 | Adult Growth Hormone Deficiency and Cardiovascular Risk | Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas | Growth Hormone Deficiency | Procedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsy | Columbia University | NULL | Terminated | 19 Years | 65 Years | Both | 8 | N/A | United States |
| 340 | EUCTR2006-005442-37-NL (EUCTR) | 08/01/2007 | 02/11/2006 | PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury | PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury | isolated growth hormone deficiency after traumatic brain injury | Trade Name: recombinant growth hormone | University Medical Center St Radboud, department of neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 341 | EUCTR2006-002278-24-AT (EUCTR) | 05/01/2007 | 10/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 342 | NCT01576861 (ClinicalTrials.gov) | January 2007 | 19/3/2012 | Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure | Growth Hormone Deficiency;Chronic Heart Failure | Drug: Somatotropin | Federico II University | NULL | Completed | 18 Years | 80 Years | Both | 28 | Phase 2 | Italy | |
| 343 | EUCTR2005-000346-36-LT (EUCTR) | 29/12/2006 | 24/10/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania | ||
| 344 | EUCTR2006-002278-24-CZ (EUCTR) | 14/12/2006 | 08/09/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | ||
| 345 | EUCTR2006-002278-24-ES (EUCTR) | 13/12/2006 | 10/03/2010 | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 346 | EUCTR2006-002278-24-DE (EUCTR) | 06/10/2006 | 15/08/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 347 | EUCTR2006-001574-24-NL (EUCTR) | 06/10/2006 | 15/06/2006 | Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency | Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency | Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries | Trade Name: Genotropin Product Name: genotropin Product Code: RVG 15790 or RVG 25480 | Radboud University Nijmegen Medical Centre, Department of Endocrinology | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Netherlands | ||
| 348 | EUCTR2005-004316-73-GB (EUCTR) | 23/08/2006 | 12/12/2005 | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan) | Product Name: strontium ranelate Product Code: strontium ranelate INN or Proposed INN: strontium ranelate Other descriptive name: N/A Product Name: Phosphate sandoz Product Code: phosphate sandoz INN or Proposed INN: phosphate sandoz Other descriptive name: N/A Product Name: growth hormone Product Code: growth hormone INN or Proposed INN: growth hormone Other descriptive name: N/A | Royal Liverpool University hospital | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 349 | EUCTR2005-005587-82-NL (EUCTR) | 08/08/2006 | 12/05/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer | Pfizer | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 350 | EUCTR2005-005587-82-IT (EUCTR) | 02/08/2006 | 23/06/2006 | A DOUBLE BLIND PARALLEL GROUP RANDOMISED MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMIC RESPONSE AND SAFETY OF PHA-794428 IN ADULT GROWTH HORMONE DEFICIENT PATIENTS - ND | A DOUBLE BLIND PARALLEL GROUP RANDOMISED MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMIC RESPONSE AND SAFETY OF PHA-794428 IN ADULT GROWTH HORMONE DEFICIENT PATIENTS - ND | Adult growth hormone deficiency AGHD . MedDRA version: 6.1;Level: PT;Classification code 10056438 | Product Code: PHA-794,428 Product Code: PHA-794,428 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 351 | NCT00596037 (ClinicalTrials.gov) | August 2006 | 7/1/2008 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: Growth hormone - LB03002 | LG Life Sciences | BioPartners GmbH | Completed | 23 Years | 70 Years | Both | 136 | Phase 3 | United States |
| 352 | EUCTR2005-005593-79-BE (EUCTR) | 31/07/2006 | 11/05/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer N.V./S.A. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Spain;Belgium;Germany;United Kingdom | |||
| 353 | EUCTR2005-005587-82-BE (EUCTR) | 03/07/2006 | 22/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer NV/SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Greece;Poland;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 354 | NCT00308464 (ClinicalTrials.gov) | July 2006 | 27/3/2006 | A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency | A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients | Growth Hormone Deficiency | Drug: PHA-794428 | Pfizer | NULL | Terminated | 18 Years | 65 Years | Both | 136 | Phase 2 | Belgium;Czech Republic;Denmark;France;Germany;Italy;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom |
| 355 | EUCTR2005-005587-82-DE (EUCTR) | 21/06/2006 | 06/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;Greece;Poland;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 356 | EUCTR2005-005587-82-SE (EUCTR) | 12/06/2006 | 02/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer AB;Pfizer Ltd | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | ||||
| 357 | EUCTR2005-005593-79-DE (EUCTR) | 09/06/2006 | 03/04/2006 | A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 32 | United Kingdom;Germany;Spain | |||
| 358 | EUCTR2005-005593-79-GB (EUCTR) | 02/06/2006 | 21/03/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 32 | Germany;United Kingdom;Spain | |||
| 359 | EUCTR2005-005593-79-ES (EUCTR) | 31/05/2006 | 04/04/2006 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency | Paediatric Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Code: PHA-794428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Code: PHA-794428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Belgium;Spain;Germany;United Kingdom | ||
| 360 | EUCTR2005-005587-82-GB (EUCTR) | 17/05/2006 | 20/04/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Code: PHA-794,428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Code: PHA-794,428 Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 136 | Sweden;Poland;Greece;Italy;Denmark;Netherlands;United Kingdom;Czech Republic | |||
| 361 | EUCTR2004-000356-17-FI (EUCTR) | 16/05/2006 | 14/03/2006 | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. MedDRA version: 7.0;Classification code 10056438 | Trade Name: NutropinAq Product Name: NutropinAq | Ipsen Scandinavia | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Finland;Denmark;Italy | ||
| 362 | NCT01342146 (ClinicalTrials.gov) | May 2006 | 21/4/2011 | Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children | Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study | Growth Hormone Deficiency | Drug: pegylated Somatropin;Drug: Jintropin AQ | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University | Completed | N/A | N/A | All | 101 | Phase 2 | NULL |
| 363 | EUCTR2005-005587-82-DK (EUCTR) | 26/04/2006 | 15/03/2006 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in adult growth hormone deficient Patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 8.1;Level: LLT;Classification code 10056438 | Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Product Name: N/A Product Code: PHA-794,428 INN or Proposed INN: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 136 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | |||
| 364 | NCT00960128 (ClinicalTrials.gov) | April 1, 2006 | 13/8/2009 | Observational Prospective Study on Patients Treated With Norditropin® | NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin® | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Adult Growth Hormone Deficiency;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Noonan Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 21249 | N/A | Argentina;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Lithuania;Luxembourg;Netherlands;Norway;Russian Federation;Saudi Arabia;Serbia;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Brazil;Czech Republic;Former Serbia and Montenegro |
| 365 | NCT00314938 (ClinicalTrials.gov) | April 2006 | 13/4/2006 | A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency | A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: PHA-794428 | Pfizer | NULL | Terminated | 6 Years | 12 Years | Both | 32 | Phase 2 | Belgium;France;Germany;Israel;United Kingdom;Spain |
| 366 | NCT00294619 (ClinicalTrials.gov) | April 2006 | 20/2/2006 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency. | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: growth hormone | LG Life Sciences | BioPartners GmbH | Completed | 23 Years | 70 Years | Both | 147 | Phase 3 | United States |
| 367 | EUCTR2005-000384-26-IT (EUCTR) | 23/03/2006 | 02/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency | Growth hormone deficiency in adult MedDRA version: 6.1;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: Somatropin | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Italy;Sweden | |||
| 368 | EUCTR2005-001315-22-AT (EUCTR) | 09/03/2006 | 18/01/2006 | The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. | The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. | We plan to study healthy aging subjects. | Trade Name: Aricept Product Name: Aricept Product Code: Donepezil | Ludwig Boltzmann Gesellschaft | NULL | Not Recruiting | Female: yes Male: yes | 80 | Austria | |||
| 369 | EUCTR2005-004478-26-SE (EUCTR) | 13/01/2006 | 28/10/2005 | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours. | Trade Name: Norditropin SimpleXx Product Name: Norditropin SimpleXx INN or Proposed INN: somatropin | Karolinska universitetssjukhuset | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 370 | NCT00517062 (ClinicalTrials.gov) | January 2006 | 15/8/2007 | Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates | Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults | Growth Hormone Deficiency | Drug: Growth hormone (Genotropin);Drug: Placebo | Oregon Health and Science University | NULL | Completed | 18 Years | 75 Years | Both | 16 | Phase 0 | United States |
| 371 | NCT00362063 (ClinicalTrials.gov) | January 2006 | 8/8/2006 | 304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency | Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (Nutropin) | Baylor College of Medicine | Genentech, Inc. | Active, not recruiting | 1 Month | 17 Years | All | 20 | N/A | United States |
| 372 | EUCTR2005-000384-26-DE (EUCTR) | 20/12/2005 | 02/06/2006 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;Spain;Sweden | ||
| 373 | EUCTR2005-000384-26-AT (EUCTR) | 10/11/2005 | 10/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | BioPartners | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 374 | EUCTR2005-000384-26-SK (EUCTR) | 27/10/2005 | 19/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 375 | EUCTR2005-000384-26-GB (EUCTR) | 21/10/2005 | 17/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 376 | EUCTR2004-004292-11-SE (EUCTR) | 06/10/2005 | 05/08/2005 | Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO | Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO | This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design. | Trade Name: Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin) Product Name: Norditropin SimplexX Product Code: NA | Endocrine Department, Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 377 | NCT00139945 (ClinicalTrials.gov) | October 2005 | 30/8/2005 | Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients | Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction | Hypopituitarism | Drug: Human acylated ghrelin | University of Aarhus | NULL | Completed | 18 Years | 60 Years | Both | 8 | N/A | Denmark |
| 378 | EUCTR2005-000384-26-CZ (EUCTR) | 30/09/2005 | 08/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 379 | EUCTR2005-000346-36-FI (EUCTR) | 22/09/2005 | 30/05/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 380 | EUCTR2005-000384-26-SE (EUCTR) | 13/09/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 381 | NCT00271518 (ClinicalTrials.gov) | September 2005 | 29/12/2005 | Treatment of Children With Insufficient Secretion of Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone | Growth Hormone Deficiency (GHD) | Drug: growth hormone (somatropin) | LG Life Sciences | BioPartners GmbH | Active, not recruiting | 3 Years | 11 Years | Both | 144 | Phase 3 | United States |
| 382 | NCT00149708 (ClinicalTrials.gov) | September 2005 | 6/9/2005 | Consequence of Lifetime Isolated Growth Hormone Deficiency | Consequence of Lifetime Isolated Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone administration for 6 months | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Genentech, Inc. | Completed | 18 Years | 80 Years | Both | 400 | N/A | Brazil |
| 383 | EUCTR2005-000384-26-ES (EUCTR) | 22/08/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 384 | EUCTR2005-000346-36-SE (EUCTR) | 18/08/2005 | 16/06/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 385 | EUCTR2005-000346-36-DE (EUCTR) | 16/08/2005 | 06/06/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 386 | NCT00397319 (ClinicalTrials.gov) | August 2005 | 8/11/2006 | Growth Hormone's Effect on the Cardiovascular System | The Role of Growth Hormone in Cardiovascular Health | Growth Hormone Deficiency | Drug: Growth Hormone | Vanderbilt University | Pfizer;National Center for Research Resources (NCRR) | Terminated | 18 Years | 65 Years | Both | 26 | N/A | United States |
| 387 | NCT00297713 (ClinicalTrials.gov) | July 2005 | 27/2/2006 | Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | Adult Growth Hormone Deficiency | Drug: ALTU-238 | Altus Pharmaceuticals | NULL | Completed | 18 Years | 60 Years | Both | 12 | Phase 2 | United States |
| 388 | EUCTR2005-001658-25-BE (EUCTR) | 16/06/2005 | 05/07/2005 | An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency. | An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency. | AGHD Adult Growth Hormone Deficiency | Product Code: PHA-794428 Product Code: PHA-794428 | Pfizer Global Research and Development | NULL | Not Recruiting | Female: no Male: yes | 8 | Belgium | |||
| 389 | NCT00256126 (ClinicalTrials.gov) | May 31, 2005 | 18/11/2005 | Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN® | Growth Hormone Deficiency;Turner Syndrome | Drug: Saizen | Merck KGaA, Darmstadt, Germany | NULL | Completed | 2 Years | 16 Years | All | 318 | Phase 4 | Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom |
| 390 | NCT01351818 (ClinicalTrials.gov) | May 2005 | 2/5/2011 | Adipocyte Function and Somtropin Deficiency | The Fayds Project: Adipocyte Function and Somtropin Deficiency | Growth Hormone Deficiency | Drug: Growth Hormone | Ferring Pharmaceuticals | Ferring SAU | Completed | 5 Years | 12 Years | Both | 62 | N/A | Spain |
| 391 | NCT00187993 (ClinicalTrials.gov) | May 2005 | 12/9/2005 | Growth Hormone Treatment of Young Growth Hormone-Deficient Adults | Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications. | Growth Hormone Deficiency | Drug: Growth hormone | University Hospital, Angers | Novo Nordisk A/S | Recruiting | 18 Years | 35 Years | Both | 30 | N/A | France |
| 392 | NCT01604161 (ClinicalTrials.gov) | May 2005 | 21/5/2012 | Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome | A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs. | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | Both | 2016 | N/A | Japan |
| 393 | EUCTR2004-000356-17-DK (EUCTR) | 19/04/2005 | 29/11/2004 | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. MedDRA version: 7.0;Classification code 10056438 | Trade Name: NutropinAq Product Name: NutropinAq INN or Proposed INN: Somatropin Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli | Beaufour Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Finland;Denmark;Italy | ||
| 394 | EUCTR2004-000356-17-AT (EUCTR) | 12/03/2005 | 02/05/2005 | Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima | Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq(tm) is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. | Trade Name: NutropinAq Product Name: NutropinAq INN or Proposed INN: Somatropin | Beaufour Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Finland;Denmark;Austria;Italy | ||
| 395 | EUCTR2004-004835-72-GB (EUCTR) | 12/01/2005 | 17/02/2005 | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | Growth hormone deficiency in adult life | Trade Name: Norditropin SimpleXx 5mg/1.5ml Product Name: Norditropin SimpleXx 5mg/1.5ml INN or Proposed INN: Somatropin Other descriptive name: Growth Hormone, GH | University of Birmingham | University Hospital Birmingham Foundation NHS Trust | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom | |||
| 396 | NCT00373386 (ClinicalTrials.gov) | January 2005 | 7/9/2006 | Growth Hormone and Endothelial Function in Children | Growth Hormone and Endothelial Function in Children | Growth Hormone Deficiency;Panhypopituitarism;Short Stature | Drug: growth hormone | Ohio State University | Nationwide Children's Hospital | Completed | 8 Years | 18 Years | Both | 12 | Phase 4 | United States |
| 397 | NCT00163189 (ClinicalTrials.gov) | January 2005 | 9/9/2005 | Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm | Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm | Growth Hormone Deficiency | Drug: Somatropin | Pfizer | NULL | Completed | N/A | N/A | All | 98 | Phase 3 | France |
| 398 | NCT00212758 (ClinicalTrials.gov) | January 2005 | 14/9/2005 | A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood | IGF-1 Generation Test in Children With Chronic Kidney Disease | Kidney Failure, Chronic;Growth Hormone Deficiency | Drug: Nutropin AQ | Oregon Health and Science University | Genentech, Inc. | Completed | 2 Years | 18 Years | All | 17 | Phase 4 | United States |
| 399 | NCT00109733 (ClinicalTrials.gov) | January 2005 | 2/5/2005 | Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency | A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS) | Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism | Biological: recombinant human growth hormone | EMD Serono | NULL | Completed | 13 Years | 25 Years | All | 31 | Phase 3 | United States |
| 400 | NCT00140413 (ClinicalTrials.gov) | December 2004 | 31/8/2005 | Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia | Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia | Growth Hormone Deficiency;Septo-Optic Dysplasia;Hypopituitarism | Drug: Nutropin AQ | Children's Hospital Los Angeles | Genentech, Inc. | Completed | N/A | 5 Years | All | 20 | Phase 4 | United States |
| 401 | NCT00468624 (ClinicalTrials.gov) | December 2004 | 2/5/2007 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) | Severe Adult Growth Hormone Deficiency | Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limb | Christie Hospital NHS Foundation Trust | NULL | Terminated | 18 Years | 70 Years | Both | N/A | United Kingdom | |
| 402 | NCT00591760 (ClinicalTrials.gov) | December 2004 | 20/12/2007 | Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial | Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study | Heart Failure;Growth Hormone Deficiency;Ischemic Heart Disease | Drug: Somatotropin | Federico II University | NULL | Completed | 18 Years | 80 Years | All | 56 | Phase 2 | NULL |
| 403 | NCT00184730 (ClinicalTrials.gov) | November 2004 | 13/9/2005 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA. | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 19 Years | 67 Years | Both | 86 | Phase 3 | Japan |
| 404 | EUCTR2004-002125-42-IT (EUCTR) | 22/09/2004 | 09/08/2007 | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EVALUATION OF GROWTH HORMONE RELEASE | INN or Proposed INN: Somatorelin | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 405 | NCT00459940 (ClinicalTrials.gov) | September 2004 | 12/4/2007 | The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients | Can Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists? | Growth Hormone Deficiency | Drug: Pioglitazone | University of Aarhus | NULL | Completed | 19 Years | 71 Years | Male | 20 | N/A | Denmark |
| 406 | NCT00489294 (ClinicalTrials.gov) | August 2004 | 19/6/2007 | Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency | An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers | Growth Hormone Deficiency | Drug: Syntropin | Phage Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 45 Years | Both | 20 | Phase 1 | United States |
| 407 | NCT00182091 (ClinicalTrials.gov) | August 2004 | 14/9/2005 | Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency | Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly | Acromegaly;Growth Hormone Deficiency;Pituitary Disease | Drug: Recombinant human growth hormone;Drug: Saline | Massachusetts General Hospital | NULL | Completed | 18 Years | 85 Years | All | 75 | N/A | United States |
| 408 | NCT00497562 (ClinicalTrials.gov) | May 2004 | 5/7/2007 | Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) | Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia | Fibromyalgia;Growth Hormone Deficiency | Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group);Drug: amitriptyline, fluoxetine and tramadol alone (control group) | Centro Medico Teknon | NULL | Completed | 18 Years | N/A | Both | Phase 2 | Spain | |
| 409 | NCT00080483 (ClinicalTrials.gov) | March 2004 | 5/4/2004 | Testosterone and Growth Hormone for Bone Loss in Men | Will Testosterone and Growth Hormone Improve Bone Structure? | Hypopituitarism;Hypogonadism;Growth Hormone Deficiency | Drug: Testosterone plus somatropin;Drug: testosterone | University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Years | N/A | Male | 35 | Phase 2 | United States |
| 410 | NCT00191165 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | N/A | 14 Years | All | 27 | Phase 3 | Italy |
| 411 | NCT01060488 (ClinicalTrials.gov) | January 2004 | 29/1/2010 | Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency | A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency | Other: GHRH+Arg, GHRH+Arg, ITT;Other: ITT, ITT, GHRH+Arg. | Merck KGaA | NULL | Completed | 18 Years | 60 Years | Both | 69 | Phase 3 | France |
| 412 | NCT00184743 (ClinicalTrials.gov) | December 6, 2003 | 13/9/2005 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 65 Years | All | 112 | Phase 3 | Japan |
| 413 | NCT00929799 (ClinicalTrials.gov) | November 2003 | 29/6/2009 | Growth Hormone and Glucose Metabolism | Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: recombinant human Growth Hormone (Genotropin® ) | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 4 | Germany |
| 414 | NCT00957671 (ClinicalTrials.gov) | November 2003 | 10/8/2009 | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Growth Hormone Deficiency;Traumatic Brain Injury | Drug: Recombinant human growth hormone | The University of Texas Medical Branch, Galveston | The Moody Foundation | Completed | 21 Years | N/A | All | 15 | Phase 4 | United States |
| 415 | NCT02693522 (ClinicalTrials.gov) | October 2003 | 19/1/2016 | Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency | Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: somatropin;Drug: Eutropin | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 18 Years | N/A | Both | 52 | Phase 3 | Korea, Republic of |
| 416 | NCT01157793 (ClinicalTrials.gov) | September 2003 | 6/7/2010 | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood | Dwarfism;Growth Hormone Deficiency | Drug: r-hGH | Merck KGaA | NULL | Completed | 14 Years | 25 Years | Both | 34 | Phase 4 | NULL |
| 417 | NCT01580605 (ClinicalTrials.gov) | July 17, 2003 | 13/4/2012 | French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin | Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 331 | France | |
| 418 | NCT01543880 (ClinicalTrials.gov) | July 2003 | 28/2/2012 | Safety and Efficacy of Long-term Somatropin Treatment in Adults | Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 20 Years | N/A | Both | 752 | N/A | Germany |
| 419 | NCT00476385 (ClinicalTrials.gov) | June 2003 | 21/5/2007 | Practicability and Acceptability of Stylomax® in Children | Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children. | Growth Hormone Deficiency | Drug: somatropine | Sanofi | NULL | Completed | 3 Years | 18 Years | Both | 12 | Phase 3 | France |
| 420 | NCT00600808 (ClinicalTrials.gov) | June 2003 | 23/7/2007 | Sustained Release Formulation of Somatropin (rDNA Origin)for Injection | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. | Growth Hormone Deficiency | Drug: BPLG-003 | BioPartners GmbH | LG Life Sciences | Completed | 4 Years | 10 Years | Both | 51 | Phase 2/Phase 3 | NULL |
| 421 | NCT00519558 (ClinicalTrials.gov) | May 31, 2003 | 20/8/2007 | Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 65 Years | All | 121 | Phase 3 | Japan |
| 422 | NCT00567385 (ClinicalTrials.gov) | March 10, 2003 | 30/11/2007 | Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 18 Years | All | 176 | Phase 4 | Turkey |
| 423 | NCT00191360 (ClinicalTrials.gov) | January 2003 | 12/9/2005 | Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency | Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | 18 Years | 65 Years | Both | 68 | Phase 3 | Japan |
| 424 | NCT00638053 (ClinicalTrials.gov) | November 2002 | 11/3/2008 | A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury | Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury | Brain Injuries;Growth Hormone Deficiency Dwarfism | Genetic: somatropin | Pfizer | NULL | Terminated | 18 Years | N/A | Both | 100 | Phase 4 | United States |
| 425 | NCT01088399 (ClinicalTrials.gov) | September 2002 | 25/2/2010 | A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults | The Global Hypopituitary Control and Complications Study | Hypopituitarism;Pituitary Insufficiency;Growth Hormone Deficiency, Adult | Drug: Somatropin (rDNA origin) | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 10673 | N/A | NULL |
| 426 | NCT01009905 (ClinicalTrials.gov) | June 24, 2002 | 5/11/2009 | An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) | Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone | Growth Hormone Disorder;Pituitary Dwarfism;Hypopituitarism | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | All | 22960 | N/A | United States |
| 427 | NCT00184678 (ClinicalTrials.gov) | February 2002 | 13/9/2005 | Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency | Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 25 Years | All | 161 | Phase 3 | Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom |
| 428 | NCT00136032 (ClinicalTrials.gov) | January 2002 | 24/8/2005 | Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women | Gender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | Massachusetts General Hospital | NULL | Completed | 18 Years | 65 Years | Female | 63 | N/A | United States |
| 429 | NCT00133354 (ClinicalTrials.gov) | November 2001 | 19/8/2005 | Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys | Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency | Hypopituitarism | Drug: Arimidex (Anastrozole);Drug: Placebo;Drug: Growth Hormone | Nemours Children's Clinic | AstraZeneca;Genentech, Inc.;EMD Serono | Completed | 11 Years | 18 Years | Male | 53 | Phase 2/Phase 3 | United States |
| 430 | NCT00458991 (ClinicalTrials.gov) | June 2001 | 9/4/2007 | rhGH Therapy on Hepatic Drug Metabolism | Recombinant Human Growth Hormone Therapy and Drug Metabolism | Growth Hormone Deficiency, Dwarfism | Drug: Dextromethorphan and Caffeine | University of Louisville | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 4 Years | 14 Years | All | 9 | N/A | United States |
| 431 | NCT01698944 (ClinicalTrials.gov) | May 16, 2001 | 1/10/2012 | Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency | Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | NULL | Terminated | 12 Years | 25 Years | All | 7 | Phase 4 | Greece |
| 432 | NCT01502124 (ClinicalTrials.gov) | May 8, 2001 | 29/12/2011 | Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency | Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 17 Years | All | 78 | Phase 3 | United States |
| 433 | NCT03018886 (ClinicalTrials.gov) | May 2001 | 6/1/2017 | Diagnosing Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test | Growth Hormone Deficiency | Other: GHRH plus arginine test | Helsinki University Central Hospital | NULL | Completed | 16 Years | 80 Years | All | 160 | N/A | Finland |
| 434 | NCT00134420 (ClinicalTrials.gov) | February 2001 | 22/8/2005 | Growth Hormone and Chromosome 18q- and Abnormal Growth | Growth Hormone Trial for Children With 18q- and Abnormal Growth | Loss of Chromosome 18q;Growth Hormone Deficiency | Drug: Nutropin AQ;Procedure: Arginine and Clonidine Stimulation Testing;Procedure: Growth Factors Laboratory Testing;Procedure: Neuropsychological Testing | The University of Texas Health Science Center at San Antonio | South Texas Veterans Health Care System;Genentech, Inc. | Completed | N/A | 18 Years | Both | 20 | Phase 3 | United States |
| 435 | NCT01543867 (ClinicalTrials.gov) | January 2001 | 28/2/2012 | Safety and Efficacy of Long-term Somatropin Treatment in Children | Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA) | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Foetal Growth Problem;Small for Gestational Age;Genetic Disorder;Turner Syndrome;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | Both | 5442 | N/A | Germany |
| 436 | NCT01563926 (ClinicalTrials.gov) | October 23, 2000 | 23/3/2012 | Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | N/A | All | 168 | Phase 3 | Israel |
| 437 | NCT00262249 (ClinicalTrials.gov) | August 2000 | 5/12/2005 | Effect of Growth Hormone in Children With Growth Hormone Deficiency | Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 3 Years | 15 Years | All | 173 | Phase 3 | United States |
| 438 | NCT00931476 (ClinicalTrials.gov) | April 6, 2000 | 30/6/2009 | A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin | A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24) | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Healthy | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 20 Years | 50 Years | Male | 86 | Phase 1 | United States |
| 439 | NCT00490191 (ClinicalTrials.gov) | January 1999 | 20/6/2007 | Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency | Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency | Hypopituitarism | Drug: Somatropin | Eli Lilly and Company | NULL | Completed | 20 Years | N/A | Both | 387 | Phase 4 | United States;France;Germany;Italy;Puerto Rico;United Kingdom |
| 440 | NCT01562834 (ClinicalTrials.gov) | October 21, 1998 | 22/3/2012 | Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients | Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 50 Years | All | 22 | Phase 4 | France |
| 441 | NCT00570011 (ClinicalTrials.gov) | June 1997 | 7/12/2007 | Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients | Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | University of Naples;University of Padua;University of Milan;University of Pisa | Completed | 18 Years | N/A | Both | 112 | Phase 3 | United States |
| 442 | NCT00006394 (ClinicalTrials.gov) | April 1997 | 4/10/2000 | Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency | Osteoporosis;Growth Hormone Deficiency | Drug: growth hormone | National Center for Research Resources (NCRR) | University of Pennsylvania | Completed | 18 Years | N/A | Both | 72 | N/A | United States | |
| 443 | NCT00174278 (ClinicalTrials.gov) | February 1997 | 9/9/2005 | Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety. | Growth Hormone Deficiency;Growth Retardation | Drug: Somatropin | Pfizer | NULL | Completed | 6 Years | N/A | Both | 14 | Phase 3 | France |
| 444 | NCT00462475 (ClinicalTrials.gov) | January 1996 | 18/4/2007 | Effect of 5 Years of GH Replacement on Atherosclerosis | Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients | Hypopituitarism;Pituitary Tumors;Growth Hormone Deficiency | Drug: Recombinant Growth Hormone, Genotropin (Pfizer) | Federico II University | NULL | Completed | 18 Years | 50 Years | Male | 20 | Phase 4 | Italy |
| 445 | NCT00497484 (ClinicalTrials.gov) | February 1995 | 5/7/2007 | Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia) | Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia) | Pseudohypoparathyroidism;Growth Hormone Deficiency, Dwarfism | Drug: recombinant human somatotropin | University of Milan | Eli Lilly and Company | Active, not recruiting | 1 Year | 18 Years | Both | N/A | Italy | |
| 446 | NCT00227253 (ClinicalTrials.gov) | September 1993 | 14/9/2005 | Chromosome 18 Clinical Research Center | The Chromosome 18 Clinical Research Center | Chromosome Aberrations;Growth Hormone Deficiency;Hypomyelination | Procedure: Determination of growth hormone status;Procedure: Measurement of growth, thyroid and sex hormone levels;Procedure: Behavior and neuropsychometric evaluations;Procedure: Audiological and ear, nose and throat examination;Procedure: Magnetic resonance imaging of the brain;Procedure: Dysmorphology evaluation;Procedure: Neurology examination;Procedure: Dental evaluation;Procedure: Speech pathology evaluation;Procedure: Psychiatric evaluation;Procedure: Orthopedic evaluation;Procedure: Ophthalmologic evaluation;Procedure: Gastrointestinal evaluation | The University of Texas Health Science Center at San Antonio | NULL | Recruiting | N/A | N/A | All | 4000 | United States | |
| 447 | EUCTR2004-000356-17-SE (EUCTR) | 11/07/2005 | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima | Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction. MedDRA version: 7.0;Classification code 10056438 | Trade Name: NutropinAq Product Name: NutropinAq | Ipsen Scandinavia | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Finland;Spain;Austria;Denmark;Italy;Sweden | |||
| 448 | EUCTR2016-003874-42-FR (EUCTR) | 06/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | |||
| 449 | EUCTR2013-000013-20-FR (EUCTR) | 25/09/2015 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge INN or Proposed INN: n/a Other descriptive name: NNC0195-0092 Trade Name: Norditropin SimpleXx 10 mg INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 32 | Phase 1 | France;Slovenia;European Union;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | |||
| 450 | EUCTR2012-002787-27-FR (EUCTR) | 23/09/2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | |||
| 451 | EUCTR2013-004468-69-RO (EUCTR) | 02/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | NA | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 452 | EUCTR2018-000231-27-IE (EUCTR) | 26/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 453 | EUCTR2016-000446-56-Outside-EU/EEA (EUCTR) | 07/03/2016 | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. - CERES | Growth deficiency due to growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: NA INN or Proposed INN: NA Other descriptive name: SOMATROPIN Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: NA Other descriptive name: SOMATROPIN | Cristália Produtos Químicos Farmacêuticos Ltda. | NULL | NA | Female: yes Male: yes | 94 | Brazil | ||||
| 454 | EUCTR2010-019374-32-DE (EUCTR) | 07/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Czech Republic;Slovakia;Germany;Slovenia | |||
| 455 | EUCTR2018-000231-27-FR (EUCTR) | 25/02/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Norway;Germany;Algeria;Japan;Korea, Republic of | |||
| 456 | EUCTR2017-000914-47-Outside-EU/EEA (EUCTR) | 23/05/2017 | Growth hormone treatment in children born small for gestational age (SGA) | A long-term, multi-centre, randomised, controlled, double-blind, parallel-group trial, investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational ageExtension to trial GHLiquid-1516: A 104-week, multi-centre, randomised, double-blind, parallel-group, no treatment controlled (open-label) trial investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for gestational age | Foetal growth problemSmall for Gestational AgeGrowth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NN-220 INN or Proposed INN: SOMATROPIN Other descriptive name: SOMATROPIN Product Name: NN-220 INN or Proposed INN: SOMATROPIN Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 86 | Phase 3 | Japan | |||
| 457 | EUCTR2015-001569-20-Outside-EU/EEA (EUCTR) | 06/07/2015 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary MedDRA version: 18.0;Level: PT;Classification code 10013883;Term: Dwarfism;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen | Merck Serono Co., Ltd. | NULL | NA | Female: yes Male: yes | 214 | Phase 4 | China | |||
| 458 | EUCTR2016-003874-42-PL (EUCTR) | 14/03/2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 INN or Proposed INN: Somatrogon Product Code: MOD-4023 INN or Proposed INN: Somatrogon Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN FOR INJECTION | OPKO Biologics Ltd. | NULL | NA | Female: yes Male: yes | 220 | Phase 3 | United States;Belarus;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Colombia;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Georgia;Germany;New Zealand | |||
| 459 | EUCTR2016-001145-11-BG (EUCTR) | 11/01/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 460 | EUCTR2012-001183-30-Outside-EU/EEA (EUCTR) | 09/03/2012 | The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay bone fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. | Double-blind trial investigating the safety and efficacy of the inhibitor anastrozole (arimidex) in delaying epiphyseal fusion and increasing height potential of adolescent males with growth hormone (GH) deficiency. | hypopituitarism MedDRA version: 14.1;Level: PT;Classification code 10021067;Term: Hypopituitarism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Arimidex Product Name: Arimidex Product Code: ZD1033 INN or Proposed INN: anastrozole Other descriptive name: ANASTROZOLE | Nemours Children's Clinic | NULL | NA | Female: no Male: yes | 53 | United States | ||||
| 461 | EUCTR2010-018781-23-NL (EUCTR) | 17/02/2010 | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate growth hormone deficiency (GHD) and non-GHD. To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency of side effects in the different tests (arginine, clonidine, protein). MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Gelatin Product Code: 3 Product Name: Arginin Product Code: 1 Trade Name: Clonidine HCl CF 0,150 mg, tabletten Product Name: Clonidine Product Code: 2 INN or Proposed INN: Clonidin Other descriptive name: CLONIDINE HYDROCHLORIDE | Top Institute Food and Nutrition | NULL | NA | Female: yes Male: yes | Netherlands | |||||
| 462 | EUCTR2009-017354-12-NL (EUCTR) | 30/07/2010 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a Product Name: Genotropin Mark VII pen Product Code: PN-180307 INN or Proposed INN: Somatropin Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: n/a | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | NA | Female: yes Male: yes | 130 | Phase 3 | Czech Republic;Slovakia;Germany;Netherlands;United Kingdom;Sweden | |||
| 463 | EUCTR2018-000231-27-NO (EUCTR) | 14/11/2019 | A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day | A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4 | Growth hormone deficiency in children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: somapacitan 5 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 10 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Product Name: somapacitan 15 mg/1.5ml PDS290 INN or Proposed INN: somapacitan Other descriptive name: SOMAPACITAN Trade Name: Norditropin FlexPro 10 mg/1.5 ml INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Novo Nordisk A/S | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | Serbia;United States;Estonia;Slovenia;Thailand;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;India;France;European Union;Canada;Denmark;Latvia;Germany;Norway;Algeria;Japan;Korea, Republic of | |||
| 464 | EUCTR2018-001989-42-DE (EUCTR) | 07/05/2021 | A research study of how well macimorelin works to find out if children have a lack of growth hormone and how safe it is | Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial | Diagnosis of growth hormone deficiency in pediatric subjects;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macimorelin Consilient Health Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: macimorelin Other descriptive name: MACIMORELIN ACETATE Trade Name: R-Gene 10 Product Name: Arginine Hydrochloride Product Code: NDC0009-0436-01 INN or Proposed INN: Arginine Hydrochloride Other descriptive name: ARGININE HYDROCHLORIDE Trade Name: Catapresan 75 Product Name: Clonidine Hydrochloride INN or Proposed INN: Clonidine hydrochloride Other descriptive name: CLONIDINE HYDROCHLORIDE | Aeterna Zentaris GmbH | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Serbia;Czechia;Slovenia;Poland;Ukraine;Romania;Russian Federation;Georgia;Germany;Italy |